Johnson & Johnson Careers
Senior Design Quality Engineer- New Product Development
Requisition ID: 1185180904
DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Design Quality Engineer- New Product Development located in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Senior Design Engineer Quality Engineer- New Product Development (Mitek) should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. This individual will work in a design team setting to provide leadership and support throughout the product lifecycle. This individual should be willing to make a significant contribution to a multi-disciplinary team, must be self-motivated and have excellent written and verbal communication skills. Working in a design team setting, this individual’s major responsibilities will be as follows (but not limited to):
- Support new product development and design through design control activities.
- Learn surgical procedures and map the product solutions into potential areas of risk and liability.
- Support and conduct process verification and validation activities.
- Conduct and lead process/design/procedural failure mode effects and analysis.
- Develop risk assessment; inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams.
- Conduct audits of new suppliers as part of the new product development project teams
- Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions.
- Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Nonconforming Materials, Risk Management, etc.
- Provides leadership in the understanding of Medical Device (21 CFR 820) and HCTP (21 CFR 1271) regulations to other disciplines.
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.
- A minimum of a Bachelor's degree in a Scientific discipline is required. An advanced degree in a related field is an asset.
- A minimum of 4 years of related experience is required.
- Excellent problem solving, and decision-making skills will be required. Interpersonal skills that foster conflict resolution as it relates to technical situations will be required.
- A minimum of 4 years of work experience in a Medical Device or Tissue-Based Product industry is preferred.
- Quality engineering experience is required.
- Advanced Technical Training in Quality Engineering principle, Risk Management, Product Testing, and Sports Medicine is preferred.
- Knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 1271, and any other specific product standard is an asset.
- Experience conducting Process / Design Failure Mode Effects and Analysis is required.
- Experience leading Process Verification / Validation activities is required.
- Experience with Blueprint reading/literacy including GD&T is preferred.
- Familiarity with inspection methods and techniques is an asset.
- Process Excellence/Lean experience is preferred.
This position will be based in Raynham, MA, and will require 10% travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Depuy Orthopaedics. Inc. (6029)