Product Development Engineer

Staff Product Development EngineerAcumed LLC, 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, OregonThe 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 View email address on click.appcast.io, and please be sure to include the title and the location of the position for which you are applying.