Product Development Engineer-Maine

KMA Human Resources Consulting; Bowdoin College Grant East Township (ME); Hybrid; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health and dental insurance

401K with company match

Employee stock ownership plan

Professional development allowance

Life insurance

Health Savings Account (HSA)

DCA accounts

Onsite fitness center

Job summary

FHC, Inc. in Bowdoin, Maine, is seeking a Product Development Engineer to join onsite.

You will work in a multi-disciplinary environment focusing on new product development and manufacturing of research and clinical devices, contributing to all stages of design and development, with emphasis on electrical, mechanical or biomedical engineering. The ideal candidate has a bachelor’s in engineering, 3-5 years in engineering, strong technical writing, CAD experience, ISO 13485 knowledge, and hands-on

Qualifications

• Excellent technical writing of controlled documents (SOPs, work instructions, protocols).
• Experience working with CAD software.
• Demonstrated understanding of ISO 13485:2016 and related regulations.
• Experience working with engineering drawings.

Responsibilities

• Maintain familiarity with FHC Quality System per ISO 13485:2016.
• Initiate/contribute to engineering changes (ECs), CAPAs and bug reports as necessary.
• Contribute to development of design input requirements and product specifications.
• Originate novel designs based on design requirements.
• Review and analyze design solutions to determine suitability and functionality.
• Create prototypes to test and verification plans for new designs.
• Create and maintain production prints, assembly instructions, bills of material.
• Develop production ready processes to meet established specifications.
• Manage production processes to maintain and improve performance and reliability.

Skills

Technical writing

Documentation

Design controls

Electrical/Mechanical/ Biomedical eng

Problem solving

Education

Bachelor's degree in electrical, mechanical, or biomedical engineering, or closely related field

Associate’s degree with demonstrated experience

Tools

CAD software

Microsoft Office 365

Job description

FHC, Inc is searching for a Product Development Engineer to be based on site at their Bowdoin, Maine location. FHC, Inc. has served the neuroscience community for over 50 years. With a guiding principle of innovation through collaboration, FHC designs, manufactures, and internationally markets products that provide customizable, pioneering solutions for neuroscientists, neurologists, and neurosurgeons and has been recognized on the Best Places to Work in Maine list for 2024 and 2026.

Job Summary:

The Product Development Engineer will work in a multi-disciplinary environment with a focus on new product development and manufacturing of research and clinical devices. The engineer contributes to all phases of product design, development, and support. Technical competencies in the areas of electrical, mechanical or biomedical engineering are required.

What We Offer:

• Salary in the range of $75-85K
• Health and Dental Insurance options
• 401K with company match
• Employee Stock Ownership Plan
• Up to $1000/ year for approved professional development
• Options for Life Insurance, HSA and DCA Accounts
• Onsite fitness center, basketball courts, disc golf course
• Flexible work schedule with the opportunity for hybrid work 1-2 days/week

Qualifications:

• Bachelor’s degree in electrical, mechanical, or biomedical engineering, or closely related field required; an associate’s degree will be considered with demonstrated experience.
• 3-5 years’ experience in engineering; medical device industry experience preferred.
• Excellent technical writing of controlled documents (SOPs, work instructions, protocols).
• Experience working within the Microsoft Office 365 suite
• Demonstrated experience working with CAD software.
• Demonstrated understanding of ISO 13485:2016 and related regulations.
• Experience working with engineering drawings.
• Hands‑on experience with design controls, design verification/validation, design and development file management.

Responsibilities:

• Maintain familiarity with FHC Quality System per ISO 13485:2016.
• Initiate/contribute to engineering changes (ECs), corrective and preventative actions (CAPAs) and bug reports as necessary.
• Contribute to development of design input requirements and product specifications.
• Originate novel designs based on design requirements.
• Review and analyze design solutions to determine suitability and functionality.
• Create prototypes to test and verification plans for new designs.
• Create and maintain production prints, assembly instructions, bills of material.
• Develop production ready processes to meet established specifications.
• Manage production processes to maintain and improve performance and reliability.

FHC, Inc is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, ancestry, familial status, age, physical or mental disability, pregnancy, sexual orientation, gender identity, genetic information, veteran status, or any other characteristic protected by law.