Senior Design Quality Engineer

Philips; Washington (Washington County); Hybride; USD 103 000 - 145 000; Plein temps

Avantages offerts par ce poste

PTO

401k match

HSA contribution

Stock purchase plan

Education reimbursement

Résumé du poste

Philips seeks a Senior Design Quality Engineer to oversee hardware quality and safety risk management across the product life cycle. You will supervise design inputs, V&V activities, design transfer and field performance to ensure all requirements are met.

This is an office role with in-person collaboration, requiring on-site presence at least 3 days per week. The ideal candidate has a BS or MS in Mechanical or Electronics engineering, 2+ years in regulated medical device design, and 5+ years

Qualifications

• Bachelor's or Master's in Mechanical or Electronics Engineering or equivalent.
• 2+ years in product design with quality/engineering in a regulated environment.
• 5+ years of experience preferred.

Responsabilités

• Oversee hardware quality and safety risk management across the product life cycle.
• Provide independent oversight of design inputs, V&V, design transfer, and field performance.
• Act as single point of contact to ensure hardware design meets standards at milestones.

Connaissances

FMEAs and risk management

Medical device quality

IEC 14971 knowledge

IEC 62304/62366 knowledge

21 CFR 820 experience

Regulated environment

Quality oversight

Formation

Bachelor's or Master's in Mechanical/Electronics Engineering

Description du poste

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 Mechanical Engineering, Electronics Engineering, Science or equivalent.* 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. 5+ years of experience preferred.* Experience with FMEAs and Product Safety Risk Management preferred.* 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 $145,000 Annually.The pay range for this position in Cambridge MA is $103,000 to $145,000 AnnuallyThe pay range for this position in Reedsville PA is $103,000 to $130,000 AnnuallyThe 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, Cambridge MA, Reedsville PA. #LI-PHIThis 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.