Senior Manager, Design Assurance Engineering

As Senior Manager of Design Assurance Quality Engineering, the primary responsibility will be to work within the Quality Management System (QMS) to support the design controls process during development of new medical devices. You will apply company policy and procedures to analyze situations or data and draw conclusions. Your role involves driving engagement and development of Design Assurance team members, ensuring compliance to the QMS, and adequately staffing NPI projects. You will also manage the department budget, understand and implement QMS processes related to Design Controls, lead CAPA and QMS continuous improvement projects, and analyze complaint data for product improvements.

Must Have

• 8+ years’ experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry.
• 3+ years’ experience leading and managing people.
• Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR.
• Strong understanding of design quality tools, methods and activities.
• Demonstrated expertise in managing complex projects and implementing cultural change.
• Ability to successfully perform minimum Physical, Cognitive and Environmental job requirements.

Good to Have

• New product development experience.
• Strong statistical background preferred in reliability / verification, hypothesis testing, sampling, multi-factor analyses.

Perks & Benefits

• annual incentive bonus
• sales commission
• long-term incentives
• generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• stock purchase plan
• education reimbursement

Job Description

Senior Manager, Design Assurance Engineering

In this role you

As Senior Manager of Design Assurance Quality Engineering, the primary responsibility will be to work within the Quality Management System (QMS) to support the design controls process during development of new medical devices. You will apply company policy and procedures to work with supporting team members to analyze situations or data and draw conclusions. Assignments will include creating, reviewing and updating documents, review of product requirements, development of risk management files, auditing Design History Files and actively participating as a core team lead of new product development teams as well as supporting teammates who act as core team leads on new product development projects. The Senior Manager of Design Assurance will also update existing QMS procedures and create new QMS procedures.

Your role:

• Drive engagement within and develop Design Assurance team members. Work with teams and other Design Assurance team members to ensure compliance to the QMS
• Ensure that NPI projects are adequately staffed and supported. Build stable relationships internally. Manage department to budget.
• Understand and implement processes and intent of all aspects of the QMS related to Design Controls
• Using engineering principles, analyze situations or data to identify gaps between project work and QMS. Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects
• Develop mastery of our products and analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles

You're the right fit if:

• 8+ years’ experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry. 5+ years’ experience with a MS or higher.
• 3+ years’ experience leading and managing people. New product development experience preferred. Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR
• Strong understanding of design quality tools, methods and activities
• Strong statistical background preferred in reliability / verification, hypothesis testing, sampling, multi-factor analyses
• Demonstrated expertise in managing complex projects and implementing cultural change.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

Philips Transparency Details

The pay range for this position in San Diego, CA is $128,500 to $179,800 Annually.

The actual base pay offered may vary within the posted ranges 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

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.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to San Diego CA.

#LI-PHI

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.