Identification de l’offre d’emploi R-416151 Date d’affichage 11/14/2021 Retour aux résultats de recherche Postuler

Product Engineer

Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The Product Engineer will represent quality on product portfolio sustainment teams and assure that current product designs and the processes for manufacturing and distribution meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross-function collaborator on product lifecycle sustainment and product/process enhancement project teams for implantable medical devices. This position will also be a project leader for proactively improving process quality, conducting change management, investigating quality events, examining non-conformances and executing CAPAs.

Duties Include:

  • Work with Quality Engineers, Quality Technicians, Inspectors, and cross functional counterparts.

  • Develop Test Protocols and Final Reports to support Regulatory 510K, PMA, CE mark and International registrations.

  • Lead/support activities for continuous process improvement and production continuity.

  • Lead/support Quality Engineering Projects to improve Quality systems and Procedures.

  • Maintain design risk assessments, coordinating input from the other Sustaining team members, and manage overall risk files for devices.

  • Assess historical Design Verification Protocols and the subsequent Final Design Verification Reports including an analysis of all data and a decision on design acceptability for design and process changes.

  • Assess and maintain the product Design Input Summary (DIS), Product Performance Specification (PPS), Product Development Plan (PDP), and applicable design history documents as defined per Davol’s product development process.

  • Determine the degree of Biocompatibility testing required as per ISO10993 and company procedures. Co-ordinate the testing at an outside lab and document results.

  • Develop or assist in development of inspection and test methods per product specifications.

  • Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.

  • Develop shelf life and stability test protocols and reports as required.

Requirements:

  • Bachelor Degree in Engineering or Technical Sciences.

  • 2 years minimum experience with Bachelor Degree or 1 years minimum experience with Masters Degree in Quality Engineering or related discipline including design controls, product/process validation, risk management, and technical problem solving.

  • Experience working in a regulated industry required

  • Applied Knowledge of the requirements of FDA QSR, ISO13485 and ISO 9001, preferred

  • Must be willing to travel (domestic & international); travel up to 25% to Puerto Rico.

Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19.  Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. 

Why join us?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit https://jobs.bd.com/

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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Primary Work Location

USA RI - Warwick

Additional Locations

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Lieu de l’emploi

Warwick

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Lieu de l’emploi

Warwick

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«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
Anonyme, Franklin Lakes, NJ

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