Sr. Design Assurance Engineer

Philips; Plymouth (MA); On-site; USD 82,000 - 130,000; Full time

Job summary

An established industry player is seeking a Sr. Design Assurance Engineer to join their innovative team. In this pivotal role, you will engage in critical Design Assurance activities that support new product development, ensuring compliance with quality standards and regulations. Your expertise in risk management and design controls will be essential in driving project success. Collaborating with cross-functional teams, you will contribute to component qualification and statistical analysis, playing a key role in maintaining high-quality standards. If you have a passion for improving healthcare through technology, this opportunity is perfect for you.

Benefits

Generous PTO

401k with up to 7% match

Health Savings Account with company contribution

Stock purchase plan

Education reimbursement

Qualifications

• 5+ years of engineering experience in medical device development.
• Strong understanding of quality system regulations for medical devices.

Responsibilities

• Complete Design Assurance activities for new product development.
• Ensure effective Risk Management using various feedback sources.

Skills

Risk Management

Design Controls

Statistical Analysis

Component Inspection

Blueprint Interpretation

Education

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Chemical Engineering

Bachelor's Degree in Bio-medical Engineering

Tools

ISO 13485

ISO 14971

Job description

Job Title

Sr. Design Assurance Engineer

Job Description

Sr. Design Quality Engineer

In this role you

Serve as a core team member completing relevant Design Assurance activities on new product development projects that help ensure our overall project and business objectives. Your primary role will revolve around updating risk documents, component qualification, statistical analysis of data, design verification and process validation planning as well as quality system compliance.

Your role:

• Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Familiarity with ISO 14971, Risk Management for medical devices.
• Knowledge of how to apply Design Controls and Process Controls. Provides critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements.
• Determines and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.
• Experienced in component inspection and testing techniques; must be able to read and interpret blueprints. Works with cross functional team to complete component qualification activities.

You're the right fit if:

• Good understanding of Medical Device QSR, ISO 13485 and ISO 14971.
• Demonstrated experience working under Design Controls in phase gate new product development role. Able to analyze, trend and draw conclusion from data.
• 5+ years engineering experience.
• Bachelor's Degree in: Mechanical, Chemical or Bio-medical engineering.
• 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 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 Plymouth, MN is $82,000 – $130,000, 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 Plymouth, MN.

#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.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.