Asensus Surgical Durham, NC (On-site)
About the job
Asensus Surgical is looking for an experienced and enthusiastic Sr. Manufacturing Development Engineer. This position is primarily responsible to ensure the related manufacturing systems, processes, and methods used for product development (R&D) are designed to provide safe and effective products according to customer needs. In this role, the Sr. Manufacturing Development Engineer provides leadership, manufacturing oversight and direction, decision-making and problem-solving capabilities. Guides manufacturing engineering in areas applicable to manufacturability, process efficiency and cost control.
Who We Are
At Asensus, we are digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery. Our employees are especially passionate about the work they do and thrive in a collaborative environment that fosters creative solutions to complex problems. The work is challenging, but everyone comes to Asensus looking for a fulfilling career, and that's exactly what they find.
What You Bring
- Bachelor’s degree in Mechanical Engineering or related discipline.
- Master’s degree in business or related engineering discipline.
- 7+ years relevant manufacturing engineering experience in product development and phase-gate development process.
- Successful track record of delivering quality products to market, in the instrumentation and/or medical device industry.
- Experience in project management and planning.
- Demonstrated leadership and experience working with cross-functional teams.
- Demonstrated experience of Design for Manufacturability, Quality or Reliability engineering/QA/QS, risk analysis, product development, and verification/validation testing.
- Experience in the design and development of quality products in accordance with ISO 13485 guidelines desired.
- Proven problem-solving skills.
- Six Sigma Green/Black Belt certifications, DFSS, Lean design and manufacturing champion desired.
What You’ll Do
- Responsible for manufacturing engineering function output in the product development process.
- Responsible for Design for Manufacturability, Design for cost and Design for Service.
- Attend & participate in design reviews for product development projects.
- Guide the development of manufacturing engineering plans, execute inspection & testing strategies & activities and work further with Manufacturing and Quality Engineering on the transfer of design requirements.
- Ensure application of manufacturing engineering to product development from concept to market launch to meet business objectives.
- Participate in the evaluation and assessment of competitive products, processes or new trends that could impact our business.
- Align dedicated and shared resources cross-functionally to optimize and ensure success of new product development.
- Collaborate with Purchasing and R&D to qualify new suppliers.
- Ensure compliance with Company quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.
- Provide technical support to manufacturing to optimize production.
- All Other Essential Duties as directed.
What We Offer
- A culture driven to achieve our mission and deliver remarkable results
- Coworkers committed to collaboration and winning the right way
- Quality products that improve the lives of our customers and patients
- Ability to discover your strengths, follow your passion and find your own rewarding career
- Flexible, engaging work environment
- A competitive benefits package
At Asensus, we believe in contributing to a society that welcomes diverse voices and values differences in lived experiences, culture, religion, age, gender identity, sexual orientation, race, ethnicity, and neurodiversity. We are committed to ensuring this same environment for our employees – a culture where individuals feel safe, heard, and respected. We celebrate the uniqueness of our global workforce and know that only through inclusion, ongoing learning, and partnership can we succeed. Together we are all stronger.