What a typical day looks like:
- : Lead and scale cross-functional teams across design, engineering, and quality assurance to drive new product introductions. Foster collaboration and break down silos to achieve operational goals.
- Talent Development: Build and mentor high-performing teams, recruiting top talent and cultivating a culture of excellence and continuous learning. Implement training and leadership programs for organizational growth.
- Change Management: Drive organizational change, set clear goals, and empower teams to adapt strategies in response to evolving business needs. Maintain team morale during site expansions.
- Customer Relationship Management: Build and maintain strong relationships with medical OEM clients, leveraging industry networks to create business growth opportunities. Present complex value propositions to stakeholders effectively.
- Business Development: Align company capabilities to meet client needs, drive business growth, and oversee client onboarding while securing long-term partnerships.
- Proposal Management: Lead the development of competitive RFQs and RFPs, ensuring compliance and preserving margins.
- P&L Management: Oversee site-level P&L, manage budgets, forecasts, and cost controls to meet financial targets.
- Product Development Expertise: Establish and mature design and engineering practices in regulated medical device manufacturing, ensuring compliance with quality and regulatory standards.
- Manufacturing Optimization: Drive design for manufacturability, scaling from pilot to production while maintaining quality. Engage with advanced manufacturing technologies to enhance efficiency.
- Industry Knowledge
The experience we’re looking to add to our team:
- Bachelor’s degree in engineering or related field; advanced degree (MBA, MS Engineering) preferred.
- 10+ years of leadership experience in a highly regulated environment, ideally in medical devices or healthcare technologies.
- Proven track record of managing site-level P&L, implementing operational improvements, and directing cross-functional teams.
- Expert knowledge of FDA regulations, ISO 13485 standards, and new product introduction (NPI) processes.
- Skilled in strategic planning and change management.
- Exceptional communication and interpersonal skills, with an ability to influence across senior leadership, customers, and cross-functional teams.
What you'll receive for the great work you provide:
- Full range of medical, dental, and vision plans
- Life Insurance
- Short-term and Long-term Disability
- Matching 401(k) Contributions
- Vacation and Paid Sick Time
- Tuition Reimbursement
Design, Process & Technology Engineering