Staff Product Development Engineer - Hand & Upper Extremity

Marmon Holdings, Inc.$100K — $130K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Mechanical or Bio-Mechanical Engineering; 8+ years' experience preferred or 14+ years in medical device development.
  • Ability to mentor and supervise engineering teams and lead complex projects across disciplines.
  • Expertise in developing complex testing protocols and understanding surgical techniques and anatomy.
  • Proficient in CAD software and knowledge of FDA/ISO design control standards.
  • Effective communicator with experience in engaging Healthcare Professionals (HCPs) and clinicians.

Responsibilities

  • Mentor and supervise engineers and designers on various projects.
  • Collaborate with department leaders to shape corporate strategy.
  • Build relationships with external design resources, surgeons, and KOLs.
  • Define and manage the engineering scope for complex projects.
  • Develop and approve advanced testing protocols and Engineering Change Requests (ECRs).
  • Act as the internal reviewer/approver for Clinical Data Reports (CDRs).
  • Guide R&D and business development with market and technical insights.

Benefits

  • Support for professional development and continuous learning.
  • Access to cutting-edge technologies and processes in medical device development.
  • Opportunity to collaborate with industry experts and leaders.
  • Engagement in meaningful projects that improve patient outcomes.
Full Job Description
Acumed LLC

Location: Hillsboro, Oregon

Job Scope

The Staff Product Development Engineer drives product development from concept to commercialization - including research, planning, concept creation, specifications, testing, validation, and communication with teams, management, and customers.

Duties/Responsibilities
  • 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 (e.g., GD&T, ECO/ECR, SAP).
  • Organize and support cadaver labs with surgeons and design teams.


Qualifications
  • Education/Experience: Bachelor's degree in Mechanical or Bio-Mechanical Engineering with 8+ years' experience preferred; or 14+ years in medical device development.
  • Leadership: Ability to mentor/supervise engineers, mechanical drafters, and product designers; lead large, complex projects; communicate effectively with executives and cross-functional teams.
  • Technical Expertise: 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, Geometric Dimensioning & Tolerancing (GD&T), tolerance stack analysis, and familiarity with FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
  • Clinical & Market Insight: Effective at engaging with HCPs and surgeons, organizing cadaver labs, investigating new product opportunities, analyzing market/competition, and recommending ROI.
  • Advanced Skills (Preferred): Independent patent analysis; writing technical product papers; proficiency in multiple technical specialty areas; ability to serve as independent reviewer for multiple projects.


Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

About Marmon Holdings, Inc.

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