Johnson & Johnson Careers
Senior Systems Engineer
Requisition ID: 1696190410
DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Systems Engineer, to work on novel products for use during spine surgery.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic business in the world. DePuy Synthes Companies offers 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.
The Senior Systems Engineer, will report to the Group Manager of Enabling Technologies. This multidisciplinary engineer will have industry and R&D expertise in developing complex medical devices preferably for surgical applications, from concept to commercial launch. The Engineer will provide hands-on technical leadership during the development, transfer to manufacturing and life cycle management of electronic medical products for nerve identification during spine surgeries.
The right candidate will have solid technical knowledge to independently select best methods and approaches to solve diverse problems and make accurate and effective technical decisions under minimal supervision. Applies appropriate standards, processes, policies, procedures, and tools throughout the product/system development lifecycle, including Standard Operating Procedures (SOP’s) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.
Specific responsibilities may include:
· Collaborate with Marketing, Sales, and other Market research resources to gather market trends and customer needs in order to guide the development objectives of products
· Work cross functionally to elicit product requirements and develop System, Subsystem and Interface requirements documents. Lead/ Contribute to the process of translating user needs into requirements and System attributes.
· Lead the Risk identification activities and ensures that identified risks are addressed through the architecture, design, development and testing activities.
· Liaise with internal and external partners to address product issues, ranging from customer complaints to manufacturability issues.
· Develop or reviews test protocols, incorporating statistics and principals of experimental design. Document findings and provide recommendations and corrective guidance.
· Identifie and formulate problems, collect data through observation and experiment, and form, test, and validate hypotheses. Select and appropriately use laboratory equipment and tools, and clearly document, communicate, and summarize technical findings and results
· Proactively identify, communicate, and refer problems or coordination needs to senior staff or supervisors. Exercise sound judgment of what to share, refer, and when to seek assistance. Provide timely, accurate, and detailed background data to minimize risks or support problem-resolution or goal achievement
· Provide technical leadership to project teams, execute multi-disciplinary technical projects, and support regulatory, preclinical and clinical activities.
· Lead design reviews at the sub-assembly level and guide the work of support staff; clearly communicating instructions and technical specifications, both orally and in writing.
· Learn basic Patent policies, procedures, and business issues and becomes familiar with the competitive “Patent Landscape” as related to assigned work.
· Prepares clear and timely written and oral status reports, updates, and technical presentations. Make technical presentations to supervisors and other groups.
· Develop pre-clinical test protocols and write reports for evidence generation and support of product analytical performance.
· Analyze experimental data, develops technical conclusions, and evaluates potential applicability of recommendations.
· Coordinate and participate in all phases of product development and sustaining life cycle: requirements, architecture, design, development, verification and testing.
· Understand the architecture of the current products and provide support to development work performed by internal and external partners.
· Work with the respective teams and propose innovative ideas on how to improve design, operability, usability, stability and human factors.
· Lead technical activities working with external Hardware and Software product development partners.
· Bachelor’s Degree in an Engineering discipline– Electrical, Computer, Biomedical, Systems, or other related majors is required. Master’s degree preferred.
· A minimum of 5 years hands-on experience, in Systems Engineering, part of a technical team developing complex, multidisciplinary products is required.
· Team player, multi-tasking with good time management skills and the ability to function effectively in a cross functional environment is required.
· Good verbal and written communication skills, including ability to write technical documents, is required
· Experience with medical device development under FDA Quality Systems Regulations, CE Marking, and/ or ISO Quality Systems, is highly desired.
· Experience with Six Sigma design practices including FMEA, Design of Experiments and Applied statistics, is highly desired
· Experience in product development with knowledge of Design for Test, Design for Manufacturability, IEC 60601 compliance, and qualification testing for new products is highly desired.
· Experience developing electromechanical surgical products, is desired.
· Experience developing or utilizing Neuromonitoring and nerve localization technology, is desired.
· Experience working with startups or external partnerships for joint development is desired.
· Position requires up to 20% travel and is based in Raynham, MA.
DePuySynthes Products Inc (6149)
R&D Engineering (R&D)