Product Development Engineer-ME

Skillcloudhcm

Bowdoin, ME

On-site

Who this role is best for

Aimed at mid-level to senior engineering professionals with medical device experience who thrive in collaborative, on-site environments.

Best fit for

Candidates with 3-5 years of engineering experience and medical device background
— “3-5 years’ experience in engineering; medical device industry experience preferred.”
Individuals who can manage design controls and regulatory compliance effectively
— “Hands-on experience with design controls, design verification/validation, design and development file management.”
Engineers comfortable with creating technical documentation and maintaining production processes
— “Create and maintain production prints, assembly instructions, bills of material.”

Things to consider

The role requires on-site presence at least 3-4 days per week despite hybrid flexibility
— “Flexible work schedule with the opportunity for hybrid work 1-2 days/week”
Candidates must be prepared to work within a highly regulated environment
— “Demonstrated understanding of ISO 13485:2016 and related regulations.”

How to stand out

Highlight experience with CAD software and design validation in your resume and interviews
— “Demonstrated experience working with CAD software.”
Showcase your ability to write controlled technical documents like SOPs and work instructions
— “Excellent technical writing of controlled documents (SOPs, work instructions, protocols).”
Emphasize your familiarity with medical device manufacturing and regulatory standards
— “Experience working within the Microsoft Office 365 suite”

Pace · SteadyCollaboration · HighAutonomy · MediumDecision Impact · Team

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

develop new product designs
create prototypes
manage production processes

Typical background

electrical, mechanical, or biomedical engineering

Skills & requirements

Required

Electrical EngineeringMechanical EngineeringBiomedical EngineeringTechnical WritingCAD Software

Preferred

ISO 13485:2016Design ControlsDesign Verification/validation

Stack & domain

Electrical EngineeringMechanical EngineeringBiomedical EngineeringTechnical WritingControlled Documents (sops, Work Instructions, Protocols)Microsoft Office 365 SuiteCAD SoftwareISO 13485:2016Engineering DrawingsDesign ControlsDesign Verification/validationDesign And Development File ManagementNeuroscienceNeurologyNeurosurgery

About the role

Original posting from Skillcloudhcm via Lever

FHC, Inc
Product Development Engineer
Bowdoin, Maine
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
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 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.
Skillcloud HCM Solutions has been engaged to manage this search. NO PHONE CALLS OR RECRUITERS PLEASE
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.

Source: Skillcloudhcm careers (Lever)