Product Development Engineer – Maine

FHC Company; Maine; Hybrid; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

401(k) with company match

ESOP

Job summary

FHC, Inc. Bowdoin, Maine is seeking a Product Development Engineer to join on-site, with optional hybrid work 1-2 days per week.

The role focuses on new product development and manufacturing of research and clinical devices, contributing to all stages of design, development, and support in multidisciplinary teams. Ideal candidates have 3-5 years in engineering, background in electrical, mechanical, or biomedical fields, and strong CAD, documentation, and ISO13485 experience.

Qualifications

• Bachelor's degree in electrical, mechanical, biomedical engineering or closely related field.
• 3-5 years' engineering experience; medical device industry preferred.
• Excellent technical writing of SOPs, work instructions, protocols.
• Experience with Microsoft Office 365 suite.
• CAD software experience.
• Understanding of ISO13485:2016 and related regulations.
• Experience with engineering drawings.
• Hands-on experience with design controls, validation, and development file management.

Responsibilities

• Maintain familiarity with FHC Quality System per ISO13485:2016.
• Initiate or 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 for suitability and functionality.
• Create prototypes to test and verification plans for new designs.
• Create and maintain production prints, assembly instructions, bills of materials.
• Develop production-ready processes to meet specifications.
• Manage production processes to maintain and improve performance.

Skills

Engineering experience

Medical device industry

Technical writing

Microsoft Office 365

CAD software

ISO 13485

Engineering drawings

Design controls

Design verification/validation

Education

Bachelor's degree in engineering

Associate degree considered

Tools

MS Office 365

CAD software

Job description

FHC, Inc

Product Development Engineer

Bowdoin, Maine

FHC,Inc is searching for a Product Development Engineer to be basedon 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, andinternationallymarkets products that provide customizable, pioneering solutions for neuroscientists, neurologists, and neurosurgeons and has beenrecognizedon the Best Places to WorkinMainelist for 2024and 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
• Generous PTO, holiday pay, paid sick time
• Up to $1000/ year for approved professional development
• Options for Life Insurance, HSA and DCA Accounts
• Discount for onsite childcare services
• 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 fieldrequired;anassociate'sdegree will be considered withdemonstratedexperience.
• 3-5 years' experience in engineering; medical deviceindustry experiencepreferred.
• 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 ISO13485:2016 and related regulations.
• Experience working with engineering drawings.
• Hands-on experience with design controls, design verification/validation,designanddevelopmentfile management.

Responsibilities:

• Maintain familiarity with FHC Quality System per ISO13485:2016.
• Initiate/contribute to engineering changes (ECs), corrective and preventative actions (CAPAs)andbugreportsas necessary.
• Contribute todevelopmentof design input requirements and product specifications.
• Originate novel designs based on design requirements.
• Review and analyze design solutions todeterminesuitability and functionality.
• Create prototypes to test and verification plans fornew designs.
• Create andmaintainproduction prints, assembly instructions, bills of material.
• Develop production ready processes to meet established specifications.
• Manage production processes tomaintainand improve performance and reliability.

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.