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.
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.
Organize and support cadaver labs with surgeons and design teams.
Bachelor's degree in Mechanical or Bio-Mechanical Engineering with 8+ years' experience preferred; or 14+ years in medical device development.
Ability to mentor/supervise engineers, mechanical drafters, and product designers; lead large, complex projects; 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.
Effective at engaging with HCPs and surgeons, organizing cadaver labs, investigating new product opportunities, analyzing market/competition, and recommending ROI.
Independent patent analysis.
Writing technical product papers.
Proficiency in multiple technical specialty areas.
Ability to serve as independent reviewer for multiple projects.