Design Quality Engineer

Job Description:

The Design Quality Engineer is accountable for design quality, risk management, sustaining, and complaint investigations for Philips Image Guided Therapy products.

• Ensures that appropriate quality plans are followed with a focus on sustaining and product complaint investigations.
• Provides input to design I/O process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
• Validates key design inputs: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs.
• Maintains design history files updated.
• Provides effective input for Risk Management activities, and all design related activities during the product/system lifecycle.
• Performs routine risk management updates.
• Performs technical assessment on product quality performance and post‑market product quality analysis.
• Performs post‑market data analysis/statistics to report on product quality performance in the field and to the Business on the efficacy and efficiency of the design and product realization processes.
• Initiates field actions/CAPA when required.

How we work together:
We believe that we are better together than a part. 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.

• You have a minimum of 3+ years’ experience in FDA regulated medical device environments, with a focus on Design Assurance, Sustaining and Post Market Complaint investigations.
• You have proven experience/knowledge in Risk Management (ISO 14971), FMEA/DFMEA, Design Verification/Validation, Root Cause analysis and Defect Management.
• You have detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing product defects, design traceability, and Design for Reliability.
• You’re experienced in utilizing Post Market Surveillance (PMS) insights/data analytics to lead continuous improvement throughout all stages of the product lifecycle.
• You’re able to share knowledge, insights regarding quality standards, and regulatory requirements.
• You have a minimum of a Bachelor’s Degree (Required), in Quality, Engineering or similar disciplines.

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

The pay range for this position in Bedford, MA is $103,000 to $163,000. 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.

• 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 Bedford, MA.
• May require travel up to 10%.

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