Staff Product Development Engineer - Hand & Upper Extremity

Acumed; Addison, Northern (TX, KY); Hybrid; USD 130,000 - 180,000; Full time

Job summary

Acumed LLC is seeking a Staff Product Development Engineer for Hand & Upper Extremity. The role spans from concept to commercialization, including testing, validation, and cross-functional coordination with surgeons and external partners.

You will mentor engineers, define scope for complex projects, and ensure regulatory-compliant documentation while collaborating with manufacturing on new technologies.

Qualifications

• Bachelor's degree in Mechanical or Bio-Mechanical Engineering required.
• 8+ years’ experience in product development for medical devices or related field.
• Experience mentoring engineers and designers across multiple projects.

Responsibilities

• Lead product development from concept to commercialization, including testing and validation.
• Mentor and supervise engineers and designers across projects.
• Collaborate with leaders to shape technical strategy and work with surgeons and external resources.
• Ensure designs meet FDA/ISO design control standards and maintain proper documentation.

Skills

Mentor/lead engineers

Cross-functional collaboration

CAD/PLM proficiency

GD&T expertise

FDA QMS knowledge

Education

Bachelor’s degree in Mechanical or Bio-Mechanical Engineering

Tools

CAD/PLM tools

ERP systems (SAP)

Product development tools

Job description

## Staff Product Development Engineer - Hand & Upper ExtremityApply: Hillsboro, OR: USA\\_TX\\_Addison\\_3885 Arapaho Road: Full time: Posted Today: JR0000043832Acumed LLCAs a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.**Location:****Hillsboro, Oregon or Addison, Texas****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* **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.