Principal Systems Assurance Engineer

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Join to apply for the Principal Systems Assurance Engineer role at The Law Offices of James A. Flexer

Vacancy No VN129

Category Product and Device Engineering

Contract Type Permanent

Contract Duration

Full Time / Part Time Full Time

Location Cambridge - UK

Job Advert Your Job

Are you a systems thinker who thrives on solving complex technical challenges in a highly regulated environment? Join us at Phillips Medisize, where you will be at the forefront of innovative drug-device combination product development. As a Principal Engineer Systems Assurance Engineer, you will take a leading role in the design, development, and assurance of our smart inhaler technologies and connected medical devices.

This role is pivotal in ensuring our active medical devices meet both regulatory requirements and high-performance standards while supporting rapid product development cycles at our Cambridge site.

What You Will Do

As The Principal Engineer Systems Assurance Engineer, You Will

• Lead the design and development of mechatronic systems for medical devices, including mobile health connectivity for smart inhalers.
• Define and manage design input requirements and technical product specifications.
• Develop and maintain comprehensive Design History Files throughout the device lifecycle, covering risk assessments, design outputs, V&V, and regulatory documentation.
• Ensure alignment with applicable standards, internal processes, and regulatory expectations.
• Act as Subject Matter Expert for medical device mechatronics, offering guidance across cross-functional teams.
• Communicate technical data effectively to senior leadership and key stakeholders.
• Support the integration of device mechatronics into manufacturing processes, including process validation and industrialisation activities.
• Engage with and manage external partners and suppliers to ensure delivery against quality and technical milestones.
• Contribute to the development and improvement of internal mechatronics standards and lifecycle processes.
• Lead project planning efforts, ensuring alignment with timelines, budgets, and resource allocations.

Who You Are

What Will Put You Ahead

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the worlds largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

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Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Information Technology

Industries

Data Infrastructure and Analytics

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