Product Development Engineer-ME

Skillcloud HCM; Bowdoin College Grant East Township (ME); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health and Dental Insurance

401K with company match

Employee Stock Ownership Plan

Generous PTO and holiday pay

Job summary

FHC, Inc. in Bowdoin, Maine, is seeking a Product Development Engineer to work on-site. The role focuses on new product development and manufacturing of research and clinical devices, contributing to all phases of design, development, and support. Electrical, mechanical, or biomedical engineering competencies are required.

The engineer will operate in a multi-disciplinary environment, with emphasis on design controls, verification/validation, and documentation in a regulated quality system.

Qualifications

• Bachelor's degree in electrical, mechanical, or biomedical engineering or closely related field.
• 3–5 years of engineering experience; medical device industry preferred.
• Excellent technical writing of SOPs, work instructions, protocols.
• Experience with Microsoft Office 365 suite.
• Experience 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 ISO13485:2016.
• Initiate/contribute to engineering changes, 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

CAD software experience

Education

Bachelor's degree in electrical, mechanical, or biomedical engineering

Tools

CAD software

ISO 13485 knowledge

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.