- Bowdoin, ME USA
- May 07, 2021
Job Title: Product Development Engineer
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
- 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.
Oversee technicians and drafts-persons assisting in the development process and monitor production progress on pilot production runs of new designs.
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.
English. Additional languages beneficial
MATHEMATICAL SKILLS AND REASONING ABILITY:
Solid understanding of higher math including calculus and trigonometry, strong scientific aptitude.
CERTIFICATES, LICENSES, REGISTRATIONS:
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.
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.