Associate Manager, R&D
$125,000–$135,000 year
HybridLeesburg, Virginia, United States or Allendale, Michigan, United States
Job Summary
Coach direct reports to meet performance objectives and manage resource planning for product development and sustaining portfolios. Lead engineers, designers, and project managers while driving innovative solutions based on clinical input from surgeons and sales representatives. Manage large sustaining projects, approve verification activities, and lead design reviews to ensure regulatory compliance for submissions including 510(k), PMA, and CE Mark. Develop engineering documentation such as Design History Files and change control records while mentoring teams on design controls and risk management. Establish metrics for senior leadership and manage expense budgets to reduce costs and improve efficiency.
Required Qualifications
- Bachelor of Science in Mechanical Engineering, Biomedical Engineering, or related discipline
- 6+ years of relevant work experience
- Experience working within international regulatory requirements (FDA, EU, ROW) in the medical device industry
- Excellent verbal and written communication skills
- Ability to interface effectively with physicians, engineers, and operational personnel
- Demonstrated ability to manage multiple priorities and work with remote teams
Desired Qualifications
- Master's degree (preferred)
- Equivalent relevant experience (to Bachelor's)
- Medical device industry experience (preferred)
- Previous supervisory experience (a plus)
- Demonstrated success in product development, bringing concepts to market, and/or managing R&D sustaining activities, product transfers, NC/CAPA, or remediation
- Experience managing multiple technology projects from inception to launch
- Strong knowledge of orthopedic products (Spine preferred), including clinical issues and performance requirements
- Applied knowledge of parametric CAD packages (Creo or SolidWorks preferred)
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