Justine Chabot – FHC Careers

SUMMARY: The Product Development Engineer – Electrical will assume responsibility for sustaining engineering of FHC’s electro-mechanical and electrophysiological clinical and research systems. Where necessary the Product Development Engineer will propose projects or issue Engineering Change Orders to improve electronic device quality and ease-of-manufacture. The target candidate will seek out opportunities to reduce cost-of-goods-sold and participate in continuous improvement activities.

CORE COMPENCIES AND RESPONSIBILITIES: Other duties may be assigned.

CORE COMPENCIES

Ability to troubleshoot mixed signal circuitry and electro-mechanical systems down to the component level.
Working knowledge of C/C++ embedded firmware code. Experience programming embedded systems.
Familiarity with schematic capture and PCB layout (Altium Designer) and CAD software.
Create BOMs and prints to facilitate manufacture of circuit boards.
Ability to source replacement electronic components due to obsolescence.
Interface with external circuit board manufacturers.
Work with test labs to facilitate medical device compliance to EMC and Safety regulations.

CORE RESPONSIBILITIES

Develop and implement production ready processes to meet established specifications
Manage production processes to maintain and improve performance and reliability
Maintain familiarity with relevant portions of the FHC Quality System and perform all duties within its guidelines, specifically those pertaining to design control, software development, EC’s and CAPA. Initiate and/or contribute to engineering changes (EC’s), corrective and preventive actions (CAPA) and bug reports as necessary.
Provide reasonably accurate estimations of the amount of work required for completion of assigned product development tasks. Alert team members as early as possible if estimates change during the development process.

COLLATERAL RESPONSIBILITIES:

Maintain a positive attitude and a passion for excellence in customer service and for promoting the well-being of the company, its products and its employees.
Enthusiastically participate in company sponsored or other community events for the sake of charitable giving in the amount of 4 hours each quarter year.

SUPERVISORY RESPONSIBILITIES:

None at this time.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

EDUCATION and/or EXPERIENCE:

A Bachelors Degree in Electrical Engineering or Electronic Engineering Technology.
A two year Associates Degree in Electrical Engineering will be considered based on experience.
0-3 years experience. Medical device preferred.

LANGUAGE SKILLS:

Fluent in speaking and writing in English. Additional languages beneficial

MATHEMATICAL SKILLS ANND REASONING ABILITY:

Solid understanding of higher math including calculus and trigonometry, strong scientific aptitude.

CERTIFICATES, LICENSES, REGISTRATIONS:

None required

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk and hear. The employee frequently is required to stand; walk; and use of hands and fingers, handle, or feel. The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the professional, smoke-free work environment is usually moderate.

SUMMARY:

The Production and Shipping Technician is an entry level position that is responsible to assist in platform production and Materials management of incoming and outgoing shipments at FHC Inc., in Greenville Pennsylvania. The position requires production duties, a variety of ERP system activities and knowledge of shipping/receiving requirements. Interfacing with multiple departments to ensure the best delivery dates and methods are used to meet customers’ requirements and to assure a unique and satisfying experience for both internal and external customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Platform Production:

Assemble product following work and print instructions as specified on manufacturing job orders generated from FHC’s ERP system.
Assist customers and Engineering Dept. in planning / processing of platforms using planning software.
Troubleshoot plan and/or build issues with customers and team members.
Relieve inventory physically and/or electronically through FHC’s ERP system if needed and follow the procedures to account for all items.
Through quality control, the Production Technician will ensure the integrity of each product he/she produces and own that part of the manufacturing process.
Assure tolerances are within acceptable range. This may include use of microscopes and will require manual dexterity working with tiny components for extended periods of time.
Maintain accuracy when packaging and assembling final product while using multiple lot specific items.
Print labels from label software program and verify, in conjunction with the Quality department, the correct label is printed to be applied to the final product.
Assure quality of assembled product, including proper label placement as documented on the engineering drawing and/or quality management system work instruction.
Assist with building and inventory needs of non-platform SLS printed parts.
Participate in continuous improvement training and projects.
Prepare and process Job orders as assigned by customer orders or internal requests.
Assist manager with accounts payable invoices and general maintenance documentation.
Cross train in all areas of production, customer service and shipping to assist and train as needed.
Follows established departmental policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental, and/or infection control standards.
Performs miscellaneous job-related duties as assigned.

Shipping and Receiving:

Responsible for assisting in processing Inbound and Outbound Returns (RMAs).
Assist in maintaining records of RMA statuses including estimated dates of arrival and departure.
Prepares shipments for postal or commercial conveyance; determines most economical and efficient shipping method; selects appropriate shipping container; packs items to ensure safe delivery.
Close jobs and package parts as needed.
Prepare bills of lading; check items to be shipped against sales orders to ascertain that quantities, destination, and routing are correct.
Receives and unloads incoming materials and compares information on packing slip with purchase order to verify accuracy of shipment.
Sorts, counts, packages, insures, unpacks, and/or logs inventory in the ERP system which is shipped or received.
Inspects shipments for damages or defects; records discrepancies or damages and notifies purchasing personnel and/or Quality & Materials Management Support Technician for vendor contact.
Delivers items to requisitioning departments including return of product from the customer complaint process to the Quality, Engineering and Regulatory Group for investigation and evaluation.
Traces lost shipments and/or customer claims of lost shipments, initiates proof of delivery documents.
Maintains minimum operating inventory of shipping materials in all stockrooms ensuring pathways are clear to avoid any safety issues as well as monitors finished goods inventory and communicates MM buyer
Have a good working knowledge of the FHC’s ERP system to perform shipment releases, to recognize errors or discrepancies that will negatively impact customer experience, quality and regulatory guidelines, or safety.
Provide shipping quotes as necessary.
Maintain Pick Slips ensuring customer orders are shipped on time.
Follows established departmental policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental, and/or infection control standards.
Performs miscellaneous job-related duties as assigned.

WORK ENVIRONMENT:

SUPERVISORY RESPONSIBILITIES:

None currently

COLLATERAL DUTIES:

Maintain a positive attitude and a passion for excellence in customer service and for promoting the well-being of the company, its products, and its employees.
Conduct self in a professional manner always.
Enthusiastically participate in company sponsored community events for the sake of charitable giving in the amount of 4 hours each quarter year.
Work with other FHC personnel on projects as needed.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Self-motivated individual who is punctual and can prioritize their workload and multitask to meet deadlines.
Be highly organized, detail-oriented, and able to maintain organized electronic and paper files and records.
Proficient in office computer systems with experience in Word and Excel and the ability to quickly learn company specific software.
Good math and analytical skills.
Excellent communication skills written, verbal and telephone to provide excellent customer service to both internal customers and external contacts.
The ability to deal and work effectively within stressful situations.

EDUCATION and/or EXPERIENCE:

High School Diploma or GED required. Associates Degree, or commensurate experience preferred but not necessary.
Production/quality inspection, and/ or shipping and receiving experience is beneficial.
The position requires basic training or experience with data entry, electronic spreadsheet software, and conventional office practices, procedures, and protocols. Essential required skills include meticulous attention to detail, effective communications, and work discipline without close supervision.
Telephone manner, word processing, database, spreadsheet, organization, prioritization, and multi-tasking are necessary.

LANGUAGE SKILLS:

Fluent use of the English language (speaking and reading).
Ability to communicate effectively in a variety of settings, personalities, and job positions.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and use hands and fingers to handle or feel. The employee is regularly required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must frequently lift and/or move various sized cartons/packages typically weighing less than 50 lbs. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

CERTIFICATES, LICENSES, REGISTRATIONS:

Driver’s License

Join us in the business of changing peoples’ lives every day. FHC designs, manufactures, and internationally markets trusted products that provide customizable solutions for neuroscientists and neurosurgeons. FHC’s neurosurgery products are used in leading functional neurosurgical centers worldwide, for various therapies such as: deep brain stimulation, ablation, resection, and for movement disorders such as Parkinson’s Disease, Epilepsy, Dystonia, and Essential Tremor.

SUMMARY: The Procedural Support Specialist (PSS) is responsible for all aspects of Procedural and Technical Support and will also engage in Selling Opportunities through product demonstrations and direct interactions with customers and market partners. This position is responsible for growing both research and clinical revenue profitably (goal as mutually determined by your supervisor), within the territory he/she will be assigned through the execution of an established and comprehensive marketing and sales plan. This position will participate actively in onsite training for physicians and technical people, tradeshows and special events. This position requires frequent travel in order to provide customer service and meet the technical and training needs of FHC’s customers. The PSS will be expected to utilize presentations and demonstrations linked with interpersonal selling skills and marketing tools to achieve company defined revenue, product and project objectives. It is expected that the PSS is a product expert to the level of being able to guide product use and attend and support surgical cases. The PSS will be responsible for administration, maintenance and accuracy of market, customer and contact information through a CRM system.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned.

Provide FHC and other assigned research or clinical manufacturers (clients) with technical support, training, and repair services.
Work with clients and sales personnel for demonstrations and product issue resolution.
Provide product analysis and research input from clients to Marketing functions.
Work on assigned training and product development projects.
Teaching and training of products and systems to hospital personnel and course attendees.
Coordinate with the Regional Development Manager (RDM) to develop and execute on a specific regional sales and marketing plan, product launches, collaboration initiatives and research and clinical sales strategies each year.
Meet with potential customers, establish rapport, provide necessary product demonstrations/presentations, and successfully negotiate and close sales as identified in regional planning.
Support balanced sales and marketing efforts to both research and clinical opportunities.
Monitor, report and act on competitive activities and information
Establish and maintain relationships with customers, contacts and key strategic partners.
Assist in establishing FHC as “the” Neural MicroTargeting Worldwide” support company by assisting in coaching and training of products and processes based on personal experience and/or education.
Represent the company at trade shows and special events to promote products
Forecast, and control expenditures to conform to fiscal year sales and expense budgets.
Prepare periodic sales reports indicating potential sales and areas of proposed client base expansion.
Daily reporting that includes:
- Collect, maintain and document customer contact and partner information, opportunities, and next actions daily in the CRM system.
- Any relevant QSF85 (Field Service Reports)
- Daily submission of performance and activity metric report.
Schedule and participate in a Weekly One on One with the RSM

Be organized and be able to network and negotiate.
Promote and maintain a strong working relationship and contact with associated co-marketing alliances
Be self-directed and flexible to work evenings and weekends.

COLLATERAL RESPONSIBILITIES:

Maintain a positive attitude and a passion for excellence in customer service and for promoting the well-being of the company, its products and its employees.
Participate in company sponsored community charitable giving events approximately 4 hours each quarter year
Work with appropriate technology development personnel to develop technical procedural support documents.
Attends and supports sales and technical services at exhibitions, seminars, and other marketing venues.

SUPERVISORY RESPONSIBILITIES:

None at this time

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Must be able to travel
Self-directed and self-motivated
Customer oriented
Communications skills, written, verbal, and telephone
Ability to communicate effectively in a variety of settings and with a variety of personalities and job positions.
The ability to deal and work effectively within stressful situations
Mechanical aptitude and the ability to work with complex electronic equipment

EDUCATION and/or EXPERIENCE

Bachelor’s Degree or equivalent, preferably in Bio or Electronic Engineering or Life Sciences

LANGUAGE AND MATHEMATICAL SKILLS

Demonstrate in-depth knowledge of sales techniques and financial principles. Have ability to effectively communicate orally and in written form with internal and external customers. Fluency in verbal and written English is essential. Additional language verbal/written skills are beneficial but not required.

REASONING ABILITY

Demonstrate the ability to anticipate and solve practical problems or resolve issues.

CERTIFICATES, LICENSES, REGISTRATIONS:

Upon hire employee will be required to complete a minimum of the following:

Vendor certifications specific to hospital requests this may include, but are not limited to security clearance, drug testing, medical clearance, up to date medical and vaccination records, and written testing of operating room protocol

PHYSICAL DEMANDS:

The physical demands as described in the duties and responsibilities, are representative of those that must be met by an employee to successfully perform the essential job functions
The employee must occasionally lift and/or move more than 25 pounds
Ability to travel extensively within the defined territory

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the professional, smoke-free work environment is usually moderate. Travel is a requirement and the travel environment may fluctuate geographically and environmentally.

LOCATION:

Various US based locations will be considered.

Salary based on experience

Job Title: Product Development Engineer

Department: Engineering

SUMMARY: The Product Development Engineer will contribute to all phases of product design, development and support. Technical competencies in the areas of biomedical engineering, electrical engineering and mechanical engineering are required. Specific responsibilities will vary from project to project and shall be met by performing the following duties:

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned.

Maintain familiarity with relevant portions of the FHC Quality System and perform all duties within its guidelines, specifically those pertaining to design control, software development, EC’s and CAPA
Deliver clear and concise communication, both written and verbal, to management, other team members and end users.
Assist team members in the development of design input requirements and product specifications
Provide reasonably accurate estimations of the amount of work required for completion of assigned product development tasks. Alert team members as early as possible if estimates change during the development process
Originate novel designs based on design requirements while adhering to sound design practices
Review and analyze design solutions to determine suitability and functionality
Construct simulations and analyses, as appropriate, evaluate proposed designs
Create prototypes as appropriate to test and verify new designs
Maintain familiarity with the “state of the art” in relevant areas such as Neuroscience, medical device design and micromachining.
Maintain familiarity with typical operating room procedures and usability requirements for medical equipment, apply said knowledge to designs
Create verification plans for new designs; document and execute those plans
Maintain familiarity with regulatory safety requirements for medical and research grade equipment
Communicate with the end users of designs to gather feedback, provide technical support and troubleshoot problems
Provide field support, installation, and training on FHC systems and products
Generate procedural support documents and user manuals for developed products
Create and maintain production prints, assembly instructions, bills of material, and other documentation related to developed products
Initiate and/or contribute to engineering changes (EC’s) and corrective and preventive actions (CAPA) and bug reports
Develop and implement production ready processes to meet established specifications
Manage production processes to maintain and improve performance and reliability

COLLATERAL RESPONSIBILITIES:

Maintain a positive attitude and a passion for excellence in customer service and for promoting the well-being of the company, its products and its employees.
Enthusiastic participation in company sponsored or other community events will be considered in performance reviews.

SUPERVISORY RESPONSIBILITIES:

Oversee technicians and drafts-persons assisting in the development process and monitor production progress on pilot production runs of new designs.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

EDUCATION and/or EXPERIENCE:

A BS degree or better in the field of Biomedical Engineering, Electronic Engineering, Mechanical Engineering or equivalent. 0-3 years of Engineering work experience preferably in the Medical Device industry.

LANGUAGE SKILLS:

English. Additional languages beneficial

MATHEMATICAL SKILLS AND REASONING ABILITY:

Solid understanding of higher math including calculus and trigonometry, strong scientific aptitude.

CERTIFICATES, LICENSES, REGISTRATIONS:

None required

PHYSICAL DEMANDS:

WORK ENVIRONMENT:

Job Title: Associate Manufacturing Engineer

Department: Engineering

SUMMARY: The Associate Manufacturing Engineer works closely with Production, Quality, Materials and Engineering to help define and continually improve all manufacturing processes. This position will assist in resolving existing production issues, reviewing the existing process for improvement opportunities with regard to fixturing or other electrical/mechanical solutions, revising the process to ensure efficiency, and ensuring the process is accurately documented.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned.

Work closely with Production Management to gather feedback and suggestions towards continual improvements for production processes.
Implement manufacturing related Engineering Changes and process documentation edits.
Maintain the Preventive Maintenance and Calibration systems.
Facilitate the document control process including upkeep of appropriate records for changes as well as maintaining approved documentation.
Assist in the development and maintenance of manufacturing, quality assurance and packaging instructions and the fixturing and processes necessary to support them.
Process print redmarks and assist Production with processing of labor, BOM or other non-print redmarks.
Design and introduce equipment to error proof and/or automate processes.
Perform process and equipment validations in conjunction with Engineering and Quality.
Assist with the introduction of, and training for, new prints, processes and instructions.
Support new product development projects by providing manufacturing feasibility and definition..
Maintain familiarity with relevant portions of the FHC Quality System and perform all duties within its guidelines, specifically those pertaining to calibration and the documentation to support calibration activities.
Deliver clear and concise written and verbal communication to management, other team members and end users.
Maintain familiarity with the “state of the art” in machining and micromachining techniques, materials science, the biomedical industry, computer aided design solutions and mechanical engineering.

COLLATERAL RESPONSIBILITIES:

Maintain a positive attitude and a passion for excellence in customer service and for promoting the well-being of the company, its products and its employees.
Enthusiastically participate in company sponsored community events for the sake of charitable giving in the amount of 4 hours each quarter year.

SUPERVISORY RESPONSIBILITIES:

None

QUALIFICATIONS:

Excellent verbal and written communication skills.
Aptitude in paying close attention to detail.
Ability to analyze issues and develop corrective and preventive actions that address the root cause.
Ability to work with others of varied backgrounds and skill sets and assign tasks accordingly.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree in Engineering or Associates degree in Engineering Technology from an ABET accredited institution.
Experience in process improvement and statistical process control (SPC) is preferred.
Experience leading teams without direct supervisory responsibility is a plus.

LANGUAGE SKILLS:

English. Additional languages beneficial.

MATHEMATICAL SKILLS AND REASONING ABILITY:

Solid understanding of higher math including calculus and trigonometry, strong scientific aptitude.

CERTIFICATES, LICENSES, REGISTRATIONS:

Lean or Six Sigma green belt a plus.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; and use of hands and fingers, handle, or feel. The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT: