Sterility Engineer

Job Title
Sterility Engineer

Job Description

The Sterility Engineer is responsible for supporting the ethylene oxide sterilization program, critical to current NPI/Sustaining initiatives for Philips' Image Guided Therapy Devices (IGTD) business.

Your role:

• Assists with managing the ethylene oxide sterilization program that includes new validations, supporting ongoing production sterilization activities and annual requalification's.
• Conducts in-depth reviews of technical documentation, including test reports and supplier related documentation to ensure compliance with regulatory requirements and Philips internal processes.
• Provides sterilization guidance to product and manufacturing related changes by maintaining a clear and comprehensive record of all assessments, decisions and any necessary test reports.
• Provides support to other departments in addressing product safety issues where sterilization processing is involved along with assisting with appropriate failure investigations.
• Stays abreast of relevant regulations, standards, and industry best practices in product safety, continuously expanding knowledge and expertise to ensure compliance and drive innovation.
• Collaborates with cross-functional teams, including R&D, Engineering, and Regulatory departments, to ensure product safety is integrated throughout the development lifecycle.

You're the right fit if:

• You've acquired a minimum of 3+ years' experience working within FDA regulated medical device/lab environments, with a focus on ethylene oxide production sterilization activities, validation and annual re-qualification.
• You have proven experience supporting NPI and sustaining projects, conducting rigorous change assessments of intricate product designs, to evaluate impact on validated state of applicable sterilization processes.
• You have experience reviewing quality events related to sterilization and working cross-functionally to determine root cause and product impact.
• You're experienced working in/influencing a complex field of stakeholders across business units/functions and have proven ability/expertise to oversee/understand the broader needs related to product safety and quality to drive the right approach for each business unit/function.
• You have a minimum of a Bachelor's Degree in Biomedical Engineering, Life Sciences (Microbiology, Biology, Chemistry) or equivalent.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position

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-based 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: $91,350 to $146,150

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. 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.

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.

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.
• May require travel up to 10%.

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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.