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Staff Product Development Engineer – Hand & Upper Extremity
Marmon Holdings, Inc.. Drive product development from concept to commercialization .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in product development, engineering project management, and compliance with FDA/ISO standards. Proficient in mentoring teams, developing complex testing protocols, and engaging with healthcare professionals.
Highest-signal resume keywords
Mechanical Engineering Degree8+ Years ExperienceProficiency in 3D/2D CAD SoftwareKnowledge of FDA Quality System RegulationsAbility to Lead Complex Projects
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Product DevelopmentTesting ProtocolsGeometric Dimensioning & TolerancingTolerance Stack AnalysisEngineering Change RequestsClinical Data ReportsMarket AnalysisIndependent Patent AnalysisTechnical Product WritingSurgical Anatomy Knowledge
Soft Skills
MentoringEffective CommunicationCollaborationRelationship ManagementProblem Solving
Tools & Technologies
CAD SoftwarePLM SystemsERP SystemsECO/ECRGD&T
Certifications & Qualifications
Bachelor’s Degree in Mechanical EngineeringFamiliarity with ISO 13485
Industry Keywords
FDA Design Control StandardsClinical Data ReportsCadaver LabsHealthcare Professionals EngagementProduct Commercialization
Tech Stack
Tools & technologiesERP
About the role
Key responsibilities & impact- Drive product development from concept to commercialization
- Conduct research, planning, concept creation, specification development, testing, validation, and communication with teams, management, and customers
- Mentor and/or supervise engineers and designers across multiple projects
- Collaborate with department leaders to shape corporate and technical strategy
- Build and manage relationships with external design resources, KOLs, and surgeons
- Define and oversee engineering scope and deliverables for complex projects
- Develop and approve advanced testing protocols, methods, and Engineering Change Requests (ECRs)
- Act as internal reviewer/approver for Clinical Data Reports (CDRs)
- Guide business development and R&D with technical expertise and market insight
- Participate in technical review boards and influence product direction
- Partner with manufacturing on new technologies and processes
- Ensure product designs and documentation meet FDA/ISO design control standards, including risk management, verification/validation, and proper use of CAD/PLM and ERP systems such as GD&T, ECO/ECR, and SAP
- Organize and support cadaver labs with surgeons and design teams
Requirements
What you’ll need- Bachelor’s degree in Mechanical or Bio-Mechanical Engineering
- 8+ years’ experience
- Ability to mentor/supervise engineers, mechanical drafters, and product designers
- Ability to lead large, complex projects
- Ability to communicate effectively with executives and cross-functional teams
- Skilled in creating and advising on highly complex testing protocols, methodologies, and technologies
- Strong knowledge of surgical anatomy, techniques, and products
- Ability to independently develop solutions and intellectual property
- Proficiency with 3D/2D CAD software
- Proficiency with Geometric Dimensioning & Tolerancing (GD&T)
- Proficiency with tolerance stack analysis
- Familiarity with FDA Quality System Regulations (21 CFR Part 820)
- Familiarity with ISO 13485
- Effective engagement with HCPs and surgeons
- Ability to organize cadaver labs
- Experience investigating new product opportunities
- Ability to analyze market/competition and recommend ROI
- Independent patent analysis (preferred)
- Writing technical product papers (preferred)
- Proficiency in multiple technical specialty areas (preferred)
- Ability to serve as independent reviewer for multiple projects (preferred)
- Completion of additional job-related screening processes following a conditional offer, as permitted or required by law
Benefits
Comp & perks- Diverse learning and working opportunities
- Equal opportunity employment
- Reasonable accommodations during the application or recruiting process