Staff Product Development Engineer - Hand & Upper Extremity

Acumed; Hillsboro (OR); On-site; USD 90,000 - 120,000; Full time

Job summary

Acumed is seeking a Staff Product Development Engineer in Hillsboro, Oregon, responsible for driving product development through all stages from concept to commercialization. This role includes mentoring engineers, collaborating on technical strategies, and ensuring compliance with industry standards.

The ideal candidate has a strong background in mechanical or bio-mechanical engineering, with at least 8 years of experience in the medical device field. Strong leadership and technical expertise are essential for this role.

Qualifications

• 8+ years of experience in mechanical or bio-mechanical engineering preferred.
• Strong leadership skills to mentor and supervise teams.
• Experience with FDA Quality System Regulations and ISO 13485.

Responsibilities

• Mentor and supervise engineers across multiple projects.
• Collaborate to shape corporate and technical strategy.
• Ensure designs meet FDA/ISO standards.

Skills

Mentorship and supervision

Project leadership

Technical expertise in testing protocols

Knowledge of surgical anatomy

Proficiency in CAD software

Education

Bachelor’s degree in Mechanical or Bio-Mechanical Engineering

Tools

3D/2D CAD software

Geometric Dimensioning & Tolerancing (GD&T)

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.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [e-mail], and please be sure to include the title and the location of the position for which you are applying.