Sustaining Senior Design Assurance Engineer

Philips; Orlando (FL); On-site; USD 87,000 - 140,000; Full time

Job summary

An innovative health technology company is seeking a Senior Design Assurance Engineer to enhance product quality through effective engineering support. This role involves leading risk management processes, ensuring compliance with regulatory standards, and mentoring junior staff. The ideal candidate will have a strong background in electrical engineering, experience in a regulated industry, and a passion for improving healthcare solutions. Join a team dedicated to making a difference in the lives of others while enjoying a comprehensive benefits package and a collaborative work environment.

Benefits

Generous PTO

401k with up to 7% match

HSA with company contribution

Stock purchase plan

Education reimbursement

Qualifications

• 3+ years of experience in electrical engineering and quality engineering.
• Knowledge of regulatory requirements (21 CFR 820, ISO 13485).

Responsibilities

• Provide quality engineering support for product launches and stabilization.
• Lead risk management processes and maintain risk documentation.

Skills

Electrical Engineering Principles

Quality Engineering

Risk Management

CAPAs and NCRs

Problem Solving Tools (5 Why, Pareto, FMEA)

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Tools

Quality Management Systems

Job description

Job TitleSustaining Senior Design Assurance Engineer

Job Description

We’re looking for a highly qualified Senior Design Assurance Engineer (sustaining) to join our San Diego team.

Your role:

• Provide quality engineering support and leadership for products which includes launch and stabilization through concept, design, and development as well as representing and providing quality engineering support on commercially launched products through sustaining initiatives (design, supplier, obsolescence changes). Lead and support the development/update of product requirements, design verification strategies, design validation strategies and update of design trace matrices/DHF files in support of product design changes.

• Participate in design reviews to ensure all pre-defined requirements have been met. Lead the risk management process and on-going maintenance of the risk management file (Risk Management Plan, FMEAs, Hazard Analysis, Risk Management Report).

• Ability to perform risk assessments for product changes (design, supplier, obsolescence) and update of the risk documentation as necessary. Lead the investigation of complex product issues (CAPAs, NCRs, Issue Impact Assessments) and recommend appropriate preventive/corrective actions.

• Monitoring/trending product issues/complaints and initiating appropriate quality planning principles to resolve such issues. Ability to use quality tools for effective problem solving (5 Why, Pareto, Fish bone, FMEA). Maintain knowledge of current regulatory requirements, applicable laws and standards as well as internal quality system requirements.

• Represent Philips as appropriate in FDA, notified body, internal and external audits. Mentoring of junior staff including training, motivating and monitoring.

You're the right fit if:

• You’ve acquired 3+ years of experience with electrical engineering principles with respect to systems, sub-systems and components. Ability to thoroughly understand complex hardware systems and how the systems work/operate.

• Your skills include experience working in a regulated industry with full working knowledge of 21 CFR 820, ISO 13485 and ISO14971 medical device/safety requirements. Strong knowledge/experience with CAPAs, NCRs and product issue impact assessments through the corrections and removals evaluation process.

• You have a bachelor's degree in engineering (electrical engineering, bio-medical engineering) with a minimum of 5 years of experience or a master's degree in engineering (electrical engineering, bio-medical engineering) with a minimum of 3 years of experience.

• 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-motivated individual and a self-starter who can work independently with minimal supervision. Strong interpersonal skills, organizational skills and project management skills are essential.

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 California, Massachusetts and Washington is $97,440 to $155,904 annually.

The pay range for this position in Minnesota is $91,350 to $146,160 annually.

The pay range for this position in Florida, Colorado, and Tennessee is $87,000 to $139,200 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., Cambridge, MA., Bothell, WA., Nashville, TN., Colorado Springs, CO., Plymouth, MN., or Orlando, FL. USA

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.

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