Principal Quality Engineer (Device Development) | BioNJ Talent Services

Principal Quality Engineer (Device Development)

Contact Information
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Position Location: 
Bridgewater, NJ
Company Profile: 

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions, consumer healthcare, established prescription products and generics. More than 100,000 people at Sanofi are dedicated to making a difference in patients’ daily lives, wherever they live, and enabling them to enjoy a healthier life.

Job Description:

Principal Quality Engineer
· Assure all design, development, industrialization, and LCM activities are in compliance with Design Controls and the relevant elements of the Quality System Regulations for stand-alone devices and combination products.
· Assist in establishing specifications through design of experiments (DOE’s) and analysis of data using statistical tools and in-depth evaluation of variable factors. Exercise technical judgment in selecting methods, techniques and evaluation criteria for obtaining results.
· Oversee and provide technical input for method development, qualification [measurement system analysis (MSA’s)], as well as method transfer for all critical performance test methods.
· Work with cross-functional development teams to assist in the development of engineering studies, design verification protocols (including aging), and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
· Support Risk Assessment activities including User-, Design-, and Process- FMEAS in order to proactively identify and mitigate risks through appropriate control strategies and risk mitigation plans.
· Participate in design reviews and provide expert Quality/technical input to ensure potential problems are identified and corrected early in development to minimize impact to broader project scope/resources/budget.
· Oversee assembly process development and design transfer activities to ensure that product design has been appropriately translated into production specifications.
· Assist in the development of validation strategies for performance qualifications and process validations for stand-alone medical devices and combination products.
· Participate in product and/or process improvements and optimization utilizing Lean and Six Sigma methodologies.
· Provide expert Quality input for proposed design and/or process changes with respect to impact assessment.
· Support/lead root cause investigations and implementation of corrective actions for transversal/global issues spanning multiple products and/or sites.
Provide technical SME input and participate in supplier, customer, internal and/or regulatory agency audits as well as due diligence activities


· BS or MS degree in Electrical, Mechanical or relevant engineering discipline.
· Minimum of 10 years of (regulated) Product Development and/or Quality Engineering experience in the Medical Device, Pharmaceutical or Biotechnology industry
· Strong analytical, technical writing, verbal communication and interpersonal skills
· Thorough knowledge of quality systems, validation principles for product and manufacturing processes, and strong engineering design fundamentals
· Thorough understanding of regulations, familiarity of regulatory environment and industry trends for stand-alone devices and combination products
· Working competency of statistical programs (i.e., Minitab, SAS, etc.)
· Certified Quality Engineer (CQE) preferred
· Certified Six Sigma Green/Black Belt or equivalent preferred #LI-SA
Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Additional Job or Internship Information
Position Type: 
Full time job