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ConvaTec Principal Systems Engineer in Cambridge, Massachusetts

At ConvaTec, our vision is to develop pioneering trusted medical solutions to improve the lives we touch. We are a global medical technology business focused on serving people and care givers in the areas of advanced wound care, ostomy care, continence and critical care and infusion care. We devise, develop and manufacture innovative products and services that support people with deeply personal and challenging medical conditions, helping to improve care for them and giving them greater confidence, freedom and mobility. We are guided by our five core values, that shape the way we work, every day: Improve Care, Deliver Results, Grow Together, Own It and Do What's Right. We are a global Group, with over 9,000 employees and in 2019, our Group generated revenues of over $1.827 billion. To learn more about ConvaTec, please visit www.convatecgroup.com.Every day, our products improve the lives of millions of people around the world. We're hugely proud of this, which is why we're transforming our business to reach millions more. Join us as a Principal Systems Engineer, and you'll drive progress that really means something.

Your Key Duties and Responsibilities:

  • Owning the delivery of electro-mechanical system architecture design, system specifications and upper-level design descriptions

  • Creating documentation adhering to quality procedures, regulations, standards and industry best practices under Design Control

  • Owning Design History Files (DHF) and related records for multidisciplinary development projects for medical devices

  • Defining critical interfaces between subsystems in the integration of sophisticated software-driven electro-mechanical devices to ensure proper system function

  • System level test strategy, test specifications and protocols

  • V&V service life-cycle; plan, realize, deliver, and own

  • Participating with establishing standards on Design Verification and Validation (V&V) processes and tools

  • Hazards analysis, failure modes analysis and mitigation design

  • Supporting program management to drive design goals within the entire project team; designing goals may include product cost, size, weight, durability, manufacturability, and serviceability among others

  • Providing guidance to manufacturing process development including PFMEA review and manufacturing test criteria

  • Supporting the development of project plans by estimating the effort required to complete design tasks

    Qualifications/Education:

  • Proficiency in medical device Quality Management System regulations and standards including ISO 13485 and 21 CFR 820, with a focus on 21 CFR 820.30 Design Controls

  • Thorough knowledge and understanding of EN ISO 14971 and other risk management practices

  • Familiarity with software development, including Agile methodologies

  • MS/BS in Engineering with at least 5+ years’ experience in, Electrical, Mechanical, Software or Firmware

  • Demonstrated experience in new product development environments including embedded software, complex mechanical systems and electronics

  • Demonstrated technical leadership skills

  • Demonstrated history of inventive solutions to technical problems

  • Experience with requirements definition and management for performance, standards compliance, and testing

  • Experience with innovative first-generation product development, preferably in the medical device market

  • Experience with product testing, experimental methods and statistical techniques

  • Knowledge of manufacturing processes a plus

  • Prior experience with disposable medical products and fluid systems a plus

  • Experience with product testing, experimental methods and statistical techniques

  • Knowledge of manufacturing processes a plus

  • Prior experience with disposable medical products and fluid systems a plus

Our products make a big difference every day. So will your contribution. The work you do will mean more, because it'll make things better for your team, our business or our customers' lives. It'll inspire you to deliver to your very best. And we'll be right behind you when you do.

This is a challenge more worthwhile.

This is work that'll move you.

#LI-KS1

ConvaTec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives: ConvaTec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any ConvaTec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of ConvaTec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

If you are an active employee at ConvaTec, please do not apply here. Go to the Career Worklet on your Workday home page and View "ConvaTec Internal Career Site - Find Jobs". Thank you!

ConvaTec is changing. We’re transforming our business, fueled by a fierce determination to improve the lives of millions more customers around the world.

Our shared focus, and the sheer drive of our people, are giving us real momentum. They’re also making us a uniquely invigorating place to work. Join us and, whatever your role, you’ll be pushed and challenged every day. You’ll be supported too, empowered to spark and drive change where it matters most.

We have a uniquely dynamic, sometimes demanding environment. But if you’re motivated, and as focused on delivering for patients as we are, it’ll bring the very best out in you. You’ll never stand still. And you might just make the biggest impact of your entire career.

If you would like to know how we intend to use your data following your application please refer to our full data privacy policy on the following link: https://www.convatecgroup.com/privacy-policy/

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