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New Product Development Quality Engineer II – Mitek
Requisition ID: 5975180314
DePuy Synthes Mitek Sports Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a New Product Development Quality Engineer II, 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 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, more agile and better equipped to meet the needs of 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. DePuy Synthes is one of the largest businesses within Johnson & Johnson.
New Product Development Quality Engineer II – The Quality Engineer II should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. 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.
The Quality Engineer II will be part of a new product development team responsible for the design, development and qualification of current and new electro-mechanical devices. These activities will be supported through the design control process. This individual will work with design engineers, surgeons, manufacturing, regulatory affairs, product directors, and other team members to: develop product requirements, perform risk management, execute product testing, and ensure compliance to design controls on these new electro-mechanical devices.
This individual will be responsible for leading: root cause investigation, failure mode effects analysis, design verification/validation testing, inspection method development, acceptance criteria creation and process validation/verification. The generation of protocols and reports to clearly document the previous design control activities is a key ability. This individual will also participate / lead the qualification and design transfer activities with external manufacturers of electro-mechanical devices.
The Quality Engineer II will conduct: external audits of new suppliers as part of the new product development and internal audits of the quality system to assure adherence to corporate policies, internal standards/requirements and compliance with regulatory requirements. This individual will also support the maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions.
This individual will provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, nonconforming materials, risk management, and medical device regulations. The Quality Engineer must 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 an engineering or scientific discipline is required. An advanced degree in a related field is an asset. A degree in electrical or computer engineering / computer science is also an asset.
- 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.
- This position will also require strong analytical, writing, and interpersonal skills. Prior project management experience, gained through college co-op, internship or research is preferred. Demonstrated strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
- A minimum of 2+ years experience (work, internship, co-op, etc.) in a highly regulated industry is required. Medical Device and/or Pharmaceutical industry is preferred.
- Electrical and/or software product knowledge is preferred.
- Design control or new product development is preferred.
- Quality engineering experience is preferred.
- Hands on experience with analog/digital circuits, electrical-mechanical drivers, schematic design, layout & programmable logic (FPGA/CPLD) is preferred.
- Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.
- Experience supporting or conducting Process Verification / Validation activities is preferred.
- 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.
Depuy Orthopaedics. Inc. (6029)