- Engineering
- Bowdoin, ME USA
- Jun 16, 2023
FHC is looking for a Product Development Engineer with a focus on electrical engineering. The engineer will be responsible for assisting in developing and maintaining FHC’s medical and research product lines. The ideal candidate will have experience in a regulated industry and will have technical competencies in the areas of Engineering/Electrical Engineering and Medical Device Development. In addition to strong design competencies, the candidate will also support manufacturing operations and provide technical support for select products. This is a great opportunity for an Engineer who is passionate about Medical Devices and improving the human condition.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Maintain familiarity with relevant portions of the FHC Quality System and perform all duties within its guidelines, specifically those pertaining to design control, Engineering Changes (ECs) and Corrective and Preventive Action (CAPA).
- Deliver clear and concise communication, both written and verbal, to management, other team members and end users.
- Generate new product concepts and production assemblies leveraging skills with 3D CAD tools.
- Actively participate in all phases of the product development lifecycle including design, implementation, verification, validation and design transfer.
- Maintain familiarity with regulatory safety requirements for medical and research grade equipment.
- Generate procedural support documentation and user manuals.
- Create and maintain production prints, assembly instructions, bills of material, and other documentation related to developed products.
- Develop and 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.
EDUCATION and/or EXPERIENCE:
- Associate Degree in Engineering technology, Bachelor of Science Degree in the field of Engineering, Electrical Engineering or Biomedical Engineering, or equivalent experience.
- Preferably a minimum of 4 years of experience working in a regulated industry.
- Hands-on engineering skills with the proven ability to work well in a team environment and drive individual projects.
- Familiarity with chemicals and chemical safety is a plus.
SUPERVISORY RESPONSIBILITIES:
None at this time.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Excellent written and interpersonal communication skills are required.
LANGUAGE SKILLS:
English. Additional languages are 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:
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 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.