Uncubed
   

Quality Engineering Senior Manager - Catheters

Penumbra, Alameda, CA

Innovative Medical Devices

Duration: Full-Time


We are seeking an experienced, high caliber Senior Manager of Quality Engineering to lead, grow and develop a Quality Engineering team responsible for the quality of manufactured products, new product introductions, and site transfer projects for their assigned product areas. This senior leader will be responsible for all catheter product lines and manufacturing processes to ensure the highest product quality and assure compliance to internal procedures and applicable external standards and regulations. In this role, this person will identify and drive improvement projects to either gain efficiency, improve product quality, or drive cost down. This role will also support internal and external audits and be a subject matter expert on relevant functional processes. The business will look to this leader to manage project-related deliverables, mitigate schedule risks, and present to management as needed.

What Success Looks Like

  • Establish credibility through quality technical execution and pitch in with hands-on help as needed to keep lines running smoothly, providing guidance and development opportunities for team members
  • Oversee Quality Engineering activities as they pertain to Operations including supporting manufacturing initiatives, process validations, equipment qualifications, quality planning and developing quality plans, incoming and in-process inspection methods, process monitoring programs, manufacturing scale-up strategies, and product transfers to other Penumbra sites.
  • Support NPI by partnering with Manufacturing Engineering and R&D to define, develop, establish and implement quality requirements on new products across the manufacturing process, including incoming, in-process, and final product inspection and process monitoring requirements.
  • Provide Quality Engineering leadership, resources, and support to meet Manufacturing/Operations objectives, production forecasts, and product build plans.
  • Provide guidance and leadership for Manufacturing and Quality Engineering in production support of NCRs, CAPAs, Control Chart excursion investigations, general root cause analysis, internal and external audits, and issue trends.
  • Responsible for leading, participating in, and conducting risk management activities, including failure mode effects and analysis and other risk mitigation as needed by the QMS.
  • Monitoring production metrics data and determining the primary factors affecting product quality, yield, throughput, cost, and drive continuous improvement initiatives to meet business operational goals.
  • Oversee the development and implementation of test equipment, inspection methods and TMVs, and sampling plans.
  • Oversee development and implementation strategies that support new process, equipment, or inspection technology advancements.
  • Support Supplier Quality on technical supplier issues such as supplier changes, supplier corrective actions, supplier development/qualification activities, and second sourcing strategies.
  • Provide proactive, diligent, and fact-based communication to senior leadership, peers, and reporting team structure.
  • Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies required.
  • Be an effective leader and partner with other Engineering/business leaders to foster continuous quality compliance, cost, and proactive improvements.
  • Be a champion of Quality and disciplined problem solving (e.g. Six Sigma and Lean) throughout the organization.

What You Bring

  • Bachelor’s degree required (mechanical, biomedical, or materials engineering preferred)
  • Class III or II medical device experience (catheter experience preferred)
  • 7+ years in quality and/or manufacturing engineering, ideally desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment
  • 4+ years of people management experience, including experience completing performance reviews and career development plans, completing promotion recommendations, mentoring/coaching staff, providing constructive feedback and managing difficult conversations
  • Demonstrated performance and results in nonconformance management and reduction, value improvement, risk reduction, and cost improvement (COGs or line efficiency)
  • Strong understanding of risk management in design and manufacturing
  • Demonstrated and impactful strong project/program management and people leadership skills required
  • Support and be the subject matter expert on the functional processes during internal and external audits
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
  • Ability to work effectively within a team in a dynamic and fast-paced changing environment
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Multi-tasks, prioritizes, and meets deadlines in a timely manner
  • Strong organizational, planning, and follow-up skills and the ability to hold others accountable

Your Preferred Qualifications and Education

  • ASQ Certified Quality Engineer strongly preferred (CQE, CRE or CMQ/OE)
  • Lean Six Sigma Black Belt
  • Demonstrated and impactful experience in process improvement, product and process qualification and validation, Process Control & Monitoring (SPC)
  • Champion statistical techniques, including reliability, to design and process areas. (Minitab or equivalent)
  • Experience working in a high mix and high volume manufacturing environment.

What We Offer

  • A collaborative teamwork environment where learning is constant and performance is rewarded
  • The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases
  • A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.  Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need.  Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. 

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.

If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.

About Penumbra

PENUMBRA TODAY Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on interventional therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Penumbra

Want to learn more about Penumbra? Visit Penumbra's website.