Senior Design Quality Engineer

Mass Digital Health; Massachusetts; On-site; USD 103,000 - 143,000; Full time

Benefits offered by this job

Generous PTO

401k match (up to 7%)

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Senior Design Quality Engineer to join our health technology team. The role focuses on leading quality and safety risk management across the product life cycle, with independent design input/V&V oversight and post-market analysis.

You will serve as the project’s single point of contact to ensure hardware design meets all quality and regulatory standards in a primarily office/onsite setting.

Qualifications

• Bachelor's or Master's degree in Engineering or Science or equivalent.
• 5+ years of experience in quality, engineering, service or manufacturing in a regulated environment with Medical Device experience.
• Experience with FMEAs and Product Safety Risk Management.
• Expertise in applying Risk Management to Medical Devices (IEC 14971), Medical Device Software Life Cycle (IEC 62304), and Usability Engineering (IEC 62366, 21CFR820) is a plus.
• You must be able to meet minimum Physical, Cognitive and Environmental job requirements for this Office/Remote position.

Responsibilities

• Oversight of system and hardware quality and safety risk management throughout the product life cycle.
• Independent oversight of design input, design V&V, design transfer and product realization, and field performance to ensure design requirements are met.
• Act as single point of contact to ensure hardware design meets quality and compliance standards at milestones.
• Perform independent technical assessment on product quality performance and post-market quality analysis.

Skills

Quality Engineering

Risk Management

Regulated environment

IEC 14971

Education

Bachelor's or Master's in Engineering or Science

Job description

Job Title

Senior Design Quality Engineer

Job Description

In this role you

Will be part of a team that is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We're looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality-of-life billions for the billions of people Philips brand touches each year.

Your role:

• Accountable for oversight of system and hardware quality and safety risk management throughout the product life cycle.
• A Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
• Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
• Performs independent technical assessment on product quality performance and post-market product quality analysis

You're the right fit if:

• Bachelor's / Master's Degree in Engineering or Science or equivalent.
• 5+ years of experience, 2+ years of experience in product design as demonstrated by a role in quality, engineering, service, or manufacturing in a regulated environment with Medical Device experience.
• Experience with FMEAs and Product Safety Risk Management
• Expertise in Application of Risk Management to Medical Devices (IEC 14971), Medical Device Software Life Cycle Processes (IEC 62304), and Application of Usability Engineering to Medical Devices (IEC 62366), 21CFR820 are pluses.
• 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.

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.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Bothell WA is $103,000 to $143,000 Annually.

The pay range for this position in Cambridge MA is $103,000 to $143,000 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 Bothell WA or Cambridge MA.

#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.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.