Sr. Manager-Design Assurance Engineering

Job Title

Sr. Manager-Design Assurance Engineering

Job Description

Exciting opportunity to play an important role in improving and saving lives around the world by leading a team of Design Assurance Engineers, supporting project teams developing Image Guided Therapy Devices and Software.

Your role:

• Manage and continuously develop the Design Assurance Engineering team and competencies in Risk Management, Design Controls, Quality Engineering practices and Reliability Engineering, as well as influencing, conflict resolution, critical thinking, etcSupport resolution of complex technical issues/challenges throughout the product development life cycle and continuously monitor product field performance; identify and execute on opportunities to drive product improvements.
• Reporting to the Quality Director- Image Guided Therapy Devices-Coronary, you will collaborate with cross functional peers to: Plan project resourcing, develop and execute project-specific execution strategies across sites and geographies, act as first level of escalation for project teams, efficiently resolve team issues/blockers and seek/execute on opportunities to improve our ways of working. Leverage your deep knowledge of 21 CFR 820.30 (Design Controls) practices to ensure project teams efficiently create deliverables (particularly DHF's) that are thorough, well documented, and audit ready.
• This hybrid, San Diego, CA based role, may require travel up to 10%.

You're the right fit if:

• You've acquired a minimum of 7+ years' experience in Design Quality Engineering/Assurance in the medical device/technology industry, with 3+ years as a functional leader and demonstrated knowledge of key regulations/standards including- 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366 etc
• Your skills include driving a "Zero Defects" mindset, focusing on the identification and elimination of potential product design defects through practices such as DFSS, DfR, DfX, and similar strategies. Maintain a focus on issue prevention and supporting associated CAPA investigations.
• You have proven experience in Design Verification/Validation planning, to ensure that all requirements are adequately integrated into test plans and all associated test reports are thorough, accurate, clear, and well documented. Projects to include development of new devices as well as modifications to commercialized devices.
• You have experience supporting the development of software controlled electromechanical medical devices
• You have a minimum of a Bachelor's Degree in Engineering, preferably Electrical or Mechanical. Master's degree preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
• You're a self-starter with strong organizational leadership abilities and skilled in driving continuous improvement in a matrixed, lean-focused environment with the capacity to adapt to changing work requirements as needed.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Read more about our employee benefits.

If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details:

The pay range for this position is $108,000 to $200,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information:

All United States-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation. *Montana employees, learn more here.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.