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R&D Project Engineer

Company: United States of America
Location: Cambridge
Posted on: May 3, 2021

Job Description:

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 .Change is everywhere at ConvaTec. It's transforming our business, and helping us improve millions of lives. And we're nowhere near finished. Across every part of our business, we're pushing for better. Join us as an R Project Engineer, and you'll do the same.About the Role: Innovation is a key driver within the business moving forward and we are building a team to enable us to deliver. You will play a pivotal role within the R function, leading key technical workstreams for the New Product Development (NPD) projects within Ostomy Care RYour Key Duties and Responsibilities: Design and develop customer focused sterile and non-sterile medical devices, across multiple locations, from concept through to commercialization.Project manage technical elements of development projects (time, budget and resources).Drive Research and Development project activities within a Design Control Framework in accordance with ISO 13485 & 21CFR820 Quality Systems for Medical Devices.Lead the development and Qualification of Design Outputs, such as Material Specifications, Sub-Assembly Specifications, Finished Product Specifications, drawings and test methods.Support development and validation of new Test Methods for Design Verification and Validation Protocols and Technology Evaluations.Write technical documents to support Design Control and regulatory submission.Develop statistical sampling plans and provide statistical rationales.Contribute to Risk Management activities and other technical assessments.Provide market/conference support, including presentations (written and oral) and provide data to support product and promotional claims.Liaise with other business functions, such as Quality Management, Regulatory Affairs, Clinical Affairs, Sourcing, Operations and Marketing, during the execution of a development project.Develop good working relationships within a multidisciplinary team and opening new communication avenues to progress projects and activities effectively.Identify and foster relationships with key vendors.Maintain awareness of new technologies and opportunities and when appropriate evaluate their potential.Challenge the status quo by identifying, reporting and implementing opportunities for improvement.About You:You possess the technical knowledge around high-volume manufacturing to effectively lead R project workstreams and drive performance. You bring experience from medical device or similar product development and manufacturing operations to drive project performance and identify and implement opportunities for improvement. You thrive under pressure to deliver results individually as well as collaboratively with your team.Qualifications/Education:Minimum of a Bachelor's Degree required with a relevant technical focusMinimum of 5 years of relevant experience in R, engineering, operations or technical project managementExperience of relevant materials and processes desirable (flexible films/fabrics/injection molded parts/electro-mechanical enclosures & assemblies/bonding techniques etc.)Competent in the use of Microsoft Office (required) and Minitab (desirable)An understanding of Design Control, Process Validation and Statistical Process Control.Experience of developing and applying statistical sampling plans during development projects.An understanding of Medical Device Regulations (such as MDD, MDR, CFR) is desirable.Experience working within the Pharmaceutical or Medical Devices Industries or a similar regulated industry.Our transformation will change your career. For good. You'll be pushed to think bigger and aim for excellence. Your ideas will be heard, and you'll be supported to bring them to life. There'll be challenges. But, stretch yourself and embrace the opportunities, and you could make your biggest impact yet.This is stepping outside of your comfort zone.This is work that'll move you.#LI-KS1ConvaTec 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!

Keywords: United States of America, Cambridge , R&D Project Engineer, Other , Cambridge, Massachusetts

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