R&D Staff Engineer

About This Role

Lead R&D projects for medical devices within the Medication Delivery and Vascular Care Solutions business, focusing on design control deliverables and mentoring junior engineers.

Responsibilities

• Lead cross-functional teams through all project phases with a focus on strategy and execution of comprehensive design control deliverables.
• Mentor junior engineers and foster a collaborative environment that drives innovation.
• Write, edit, and effectively communicate technical strategies, protocols, reports, work instructions, and design reviews to diverse stakeholders.
• Analyze complex problems, develop innovative solutions, and make data-driven decisions that align with business objectives.
• Apply engineering principles for design development/analysis, including use of digital engineering tools (e.g., FEA).
• Leverage solid mechanics/materials knowledge to solve technical challenges.
• Complete statistical analysis and sample plan development.
• Drive innovation and process efficiency through continuous improvement.

Requirements

• Minimum 10 years of experience in medical device or similarly regulated industry.
• Expertise with design verification & validation strategy development and execution on medical devices/mechanical systems.
• Demonstrated track record of technical problem solving and effective product development through expert application of engineering principles.
• Design controls expertise including new product launches, post-launch changes, and governing regulations (globally).
• Proficiency in solid mechanics/mechanics of materials and good knowledge of statistical methods/tools.
• Demonstrated ability to lead technical teams and influence cross-functional stakeholders.
• Proven ability to communicate complex technical concepts clearly to diverse audiences.
• Evidence of applying analytical approaches to solve complex engineering challenges.

Qualifications

• Minimum 10 years of experience in medical device or other similarly regulated industry.

Nice to Have

• Master's Degree in Mechanical or Biomedical Engineering and 7+ years of experience.
• PhD in Mechanical or Biomedical Engineering and 5+ years of experience.
• Experience in solid modeling (SolidWorks or similar) and finite element analysis/mechanics tools (FEA).
• Experience in high-volume manufacturing processes (inclusive of injection molding and high-speed assembly).
• Experience in the development of drug delivery devices and/or combination products.
• Exposure to Chemistry and Chemical/Materials Engineering.
• Track record of successfully leading complex technical projects from concept to commercialization.
• Experience presenting to senior leadership and external regulatory bodies.
• Demonstrated ability to develop long-term technical strategies that align with business objectives.

Skills

* Required skills

Benefits

Certifications