Senior Manager R&D - IP&SS Design Development - Chemical & Biological

Senior Manager R&D – IP&SS Design Development – Chemical & Biological

As a Senior Manager R&D – IP&SS Design Development – Chemical & Biological you will lead a team of R&D Design Development Chemical and Biological engineers and scientists developing products across the Vascular Access Solutions, Assurance & Monitoring Solutions, and Peri-Operative Surgical Solutions portfolios. You will:

• Minimize project uncertainty by clearly defining scope and product requirements, aligning program timing and resources with design capability, and identifying new capabilities or capacities to develop internally or acquire externally.
• Develop component, subassembly, assembly, and product designs that are reliable and manufacturable.
• Work in concert with IP&SS R&D Product Development to maintain effective extended team resource allocation to achieve committed deliverables.
• Identify, plan, document, and execute design controls and risk management processes and procedures.
• Evaluate product functionality, performance, and safety through characterization, verification, and validation testing.
• Continuously evaluate selected designs to ensure they meet design input requirements and performance requirements while reducing project-, cost-, and timeline-risk and increasing certainty of business case attainment.
• Transfer technology design knowledge to Sustaining Engineering as products enter the market and maintain a role as technical subject matter expert to support Sustaining activities as needed.

Ensure the health and vitality of our IP&SS new product development portfolio and products by:

• Defining and implementing vision, culture, and development focus areas for the team and our people.
• Leading by example with a hands‑on, player‑coach approach.
• Fortifying medical device rigor, empowering our team, driving accountability, and increasing engagement.
• Developing product and technology strategies and guiding their implementation to maintain viable product portfolios while ensuring inclusion of feature, process, and technology improvements that address unmet needs and improve customer satisfaction and patient outcomes.
• Contributing to organic technology‑focused ideation and feasibility activities.
• Contributing to the review and due diligence of inorganic opportunities.
• Leading experienced professional and/or specialist employees who exercise significant latitude and independence.

• Bachelor’s Degree in an applicable technical field.
• Ten years of relevant experience.
• Experience in a regulated industry (medical devices preferred) utilizing design controls to design, develop, verify, validate, and commercialize new products.
• Previous experience managing people, leading teams, and developing/managing budgets.
• Expertise in project technical leadership with the ability to oversee multiple projects simultaneously.
• Experience with and working knowledge of ISO
  9000, FDA, and GMP requirements including product requirements, specification documents, and risk management files.
• Proficiency in MS Office applications (Word, Excel, PowerPoint), strong written and verbal communication skills, and ability to read and understand technical drawings.
• Strong working knowledge of processes and equipment common to medical device manufacturing (additive manufacturing, machining, extrusion, injection molding, coating, adhesive and thermal bonding, die cutting, flat film converting, automated and semi‑automated manufacturing equipment, etc.).
• Master’s degree in an applicable technical or business field (preferred).
• Demonstrated ability to evaluate, mentor, and grow engineering talent.
• Excellent analytical and problem‑solving skills, familiarity with statistical techniques, experience with scientific methods and Design of Experiments.
• Ability to understand and resolve complex technical and business system issues.

Hybrid Eligible: required on‑site at Eagan, MN office at least 3 days per week. Travel may include up to 15% domestic/international travel. Relocation assistance may be authorized for qualified candidates.

Applicable to US applicants only. The expected compensation range is $187,600 – $257,950,…