This position is responsible to support the Global Operations Advanced Manufacturing Engineering (AME) – NPD team in developing, qualifying, and launching new products into production for the Smith and Nephew Sports Medicine Franchise.Senior NPI Engineer will be the operations new product development representative and is responsible for working with cross-functional teams both locally and at various manufacturing sites to support the goals and objectives of Smith and Nephew according to strategic plans. This position is responsible for ensuring that timeline milestone commitments are achieved while meeting all safety quality and cost requirements.We are looking for a motivated, driven, and technically curious individual that can drive execution in a very diverse and challenging environment. This individual will be working in both cross-functional group settings as well as independently with the support of a technically strong, experienced, and highly motivated team.Job level (for internal use only): P4What will you be doing?Works with partner groups at manufacturing sites to gain alignment and support to achieve project objectives.Responsible for equipment specification creation, equipment acquisition and implementation.Leads Capital Expenditure requests including submission, forecasting, tracking and implementation for new equipment and tooling.Develops and implements tooling, fixturing and gages to support NPD activities.Leads design for manufacturability (DFM) and process development efforts for new products in the pipeline.Creates process flow charts and works with the Industrial Engineering team in developing assembly line layouts, capacity analysis, and propose solutions to optimize process time and cost for new products.Performs COGs analysis for NPD decision making (includes assisting in the make vs buy and make vs make analysis for components).Supports design technical review and design transfer review.Writes MVP, PFMEA, Process Mapping and Critical to Quality documentation.Develops and evaluates new processes through lab studies, Design of Experiments (DOE), tolerance stacking and testing methods.Creates specifications, drawings, process instructions (MPIs), bills of materials (BOMs) and routers.Coordinates and manages prototype, verification, and validation buildsLeads problem solving, root cause analysis and implementation of sound engineering solutions. Owns and responds NC and CAPA investigations as applicable.Working knowledge of key Medical standards such as FDA CFR Part 820 and ISO 13485. Understands medical device requirements for Installation Qualification (IQ), Operation Qualification (OQ), Process Qualification (PQ) and Test Method Validation (TMV) as it relates to production equipment validation.Responsible for protocol development and driving equipment, process, test method and software qualifications when appropriate.Mentors and guides less experienced engineers.Effectively listens to others by asking clarifying questions to gain understanding of other points of view.Duties and responsibilities may change as business needs change.What will you need to be successful?Education: Bachelor’s degree in science or engineering (Electronics, Electrical, Mechatronics, Mechanical, Material, Industrial or Chemical). Master’s degree preferred (MBA or Engineering)Experience: At least 3 years professional work experience in new product development, complex process development, design for manufacturing and driving design change.Minimum 8 years of experience in medical devices industry, preferably releasing and/or updating products.Experience in various metal, plastic and/or electronics manufacturing methods, including but not limited to welding, machining, injection molding, circuit assembly, electrical testing, and programming.Experience in project management including creating project plans, determining dependencies & critical path, and tracking milestones & deliverables.Demonstrated track record for delivering new products into production while meeting schedule and quality commitments.Working knowledge of Design Controls and Process Validation.In-depth knowledge of operations deliverables / documentation is preferred.Demonstrated track record for delivering new products into production while meeting schedule and quality commitments.Working knowledge of Design Controls and Process Validation.In-depth knowledge of operations deliverables / documentation is preferred.Experience solving complex technical issues and driving sound solutions with R&D.Certification: Solid Works is a plusCompetencies: English level: C1 minimum.Excellent project management, communication, and leadership skills.Excellent analytical skills.Ability to understand, interpret, follow, and improve Quality SystemsAssembly fixture design and fabrication knowledge. GD&T knowledge and understanding is a plus.Proficiency in statistical tools for data-driven analysis and decision making (MSA, capability analysis, hypothesis testing, ANOVA, DOE, and other statistical studies).Excellent interpersonal communication skillsStrong verbal and written communication and presentation skills.You. UnlimitedInclusion and equity: Committed to Welcoming, Celebrating and Thriving, learn more about on our website (Other reasons why you will love it here!Your future: stock purchase program, referral bonus, subsidy in transport and food, recognition program.Work/Life Balance: Extra days off, birthday off, voluntary hours.Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave,Flexibility: Hybrid work model (for more professional roles), flexible schedules.Training: Training program, unlimited learning.Extra perks: employees association, and more…Stay connected by joining our .We're more than just a company - we're a community! Follow us on to see how we support and empower our employees and patients every day.Check us out on for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our and learn more about our mission, our team, and the opportunities we offer.
