Product Development Engineer- Pennsylvania

Skillcloudhcm
Greenville, PA
On-site

Who this role is best for

Aimed at mid-level to senior engineering professionals who can navigate medical device regulations and contribute to cross-functional product development.

Best fit for

  • Candidates with 3-5 years of engineering experience and a background in medical device development
    — “3-5 years’ experience in engineering; medical device industry experience preferred.”
  • Individuals with hands-on experience in design controls and validation processes
    — “Hands-on experience with design controls, design verification/validation, design and development file management.”

Things to consider

  • The role requires in-person presence at the Greenville, PA location
    — “based on site at their Greenville, PA location”

How to stand out

  • Highlight your experience with CAD software and production file management in your resume
    — “Demonstrated experience working with CAD software.”
  • Showcase your ability to write technical documentation and manage design controls
    — “Excellent technical writing of controlled documents (SOPs, work instructions, protocols).”
  • Emphasize any prior work with medical devices or neuroscience-related products
    — “medical device industry experience preferred.”
  • Demonstrate familiarity with ISO 13485:2016 in your interview responses and resume
    — “Demonstrated understanding of ISO 13485:2016 and related regulations.”
  • Include examples of initiating engineering changes or CAPAs in your professional experience
    — “Initiate/contribute to engineering changes (ECs), corrective and preventative actions (CAPAs) and bug reports as necessary.”
Pace · SteadyCollaboration · MediumAutonomy · MediumDecision Impact · Individual

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

What success looks like

  • contributed to all phases of product design, development, and support
  • initiated/contributed to engineering changes, CAPAs, and bug reports
Typical background
Bachelor’s degree in mechanical or biomedical engineering3-5 years of engineering experience

Skills & requirements

Required

Product DevelopmentMechanical EngineeringBiomedical EngineeringTechnical WritingCAD SoftwareISO 13485:2016 ComplianceDesign ControlsDesign Verification/validation

Stack & domain

Mechanical EngineeringBiomedical EngineeringTechnical WritingControlled DocumentsSopsWork InstructionsProtocolsMicrosoft Office 365CAD SoftwareISO 13485:2016Engineering DrawingsDesign ControlsDesign Verification/validationDesign And Development File ManagementTeamworkCommunicationProblem-solvingAdaptabilityAttention To DetailQuality ManagementProcess ImprovementNeuroscienceNeurologyNeurosurgeryMedical Device Industry

About the role

Original posting from Skillcloudhcm via Lever

FHC, Inc

Product Development Engineer

Greenville, Pennsylvania

FHC, Inc is searching for a Product Development Engineer to be based on site at their Greenville, PA 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.

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 mechanical or biomedical engineering are required.

What We Offer::

  • Salary in the range of $75-85K
  • Health, 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
  • Positive, collaborative, team focused work environment
  • Convenient Greenville, PA location

Qualifications::

  • Bachelor’s degree in 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)

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