Product Development Engineer-ME

FHC, Inc

Product Development Engineer

Bowdoin, Maine

FHC, Inc is searching for aProduct Development Engineer to be based on site at theirBowdoin, 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, mechanicalor biomedical engineering are required.

What We Offer:

• Salary in the range of $75-85K

• Health andDental Insuranceoptions

• 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, HSAand 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 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.