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Senior Design Engineer, R&D
4 weeks ago
Senior Mechanical Design Engineer
Location: Stryker R&D Innovation Centre, Cork
Role Summary:
Designs, develops, refines and evaluates mechanical components assemblies or subsystems for mechanical and/or electro-mechanical medical devices and implants. Uses concurrent engineering and rapid prototyping techniques to reduce product time to market whilst adhering to project deadlines and product costs. You will plan and execute successful product development projects, occasionally leading and training team members on technical aspects of product commercialization. You will provide post-market design and product application support for a wide range of medical devices, performing engineering analysis and providing product expertise to Operations and QA/RA teams for reliability improvement, risk management, cost reduction, and CAPA activities. Products include Minimally Invasive Orthopaedic Saw Blades for total joint surgery, blades for micro orthopaedics/small joint surgery, Implant Revision Instruments, High Speed Neuro-Spine and ENT Burs/Drills, Cranial Perforators, Knee/Hip Arthroscopy Blades and Burs, Sinus Shaver Blades, Ultrasonic tips for bone and tumor removal, and disposable electrosurgical devices for a range of surgical applications.
What you will do?
1. Development of medical device products from concept to production. Participation in multifunctional product development teams and liaison with marketing for the development and specification of new concepts for medical device products.
2. You will work with a highly creative design team in and out of the company to invent and develop innovative successful new product concepts. Create smart, innovative solutions to mechanical design challenges. Conduct research in problem areas of considerable scope and complexity.
3. Evaluate and optimize concepts for mechanical function and manufacturability. Develop product designs and create prototypes from customer concepts and/or specs to test and validate ideas.
4. Will determine and implement design approaches and parameters and conduct feasibility studies on new designs. Will analyze equipment to establish operating data, conduct experimental tests and evaluate the results. Lead and/or participate in design review meetings.
5. Will select components and equipment based on analysis of specifications, reliability, and regulatory requirements. Work with advanced quality engineers to develop component-specific testing and inspection protocols.
6. Liaison with advanced process development and supply chain personnel for the specification and sourcing of raw materials and suppliers.
7. Communicate with suppliers, advanced manufacturing engineering, and advanced operations to resolve issues and optimize design for manufacturability and efficiency. Will ensure designs are cost-efficient, manufacturable, and reliable.
8. You will lead and contribute significantly in efforts to identify, determine product requirements, generate production drawings for parts and assemblies, and develop and manage full product design documentation.
9. You will support investigation and root cause analysis of customer complaints and field returns using engineering analysis techniques and problem-solving methodologies.
10. You will participate in or lead CAPA projects, working closely with cross-functional teams including Manufacturing Engineering and Quality Engineering to identify and remediate product quality and process issues.
11. Working within the Change Control Process, you will provide design support to and lead Engineering Change Requests including manufacturing process changes, product improvements, Supplier Change Requests, Supplier Transfers, and Supplier PPAP.
12. You will provide design and product application support for operations engineering cost reduction projects.
13. This position is accountable for achieving product performance and quality objectives, project planning, and effective execution, as well as communicating project status and escalating issues when appropriate.
14. Independently determines and develops approach to resolving end customers' product-related issues, through problem-solving and troubleshooting product design, and product training.
What you need?
Bachelor Engineering Degree (Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Electrical Engineering or Materials Science) with a minimum of 2 years or more experience. A Masters degree in an engineering field is desirable.
1. Excellent interpersonal skills - able to express ideas and collaborate effectively with multidisciplinary teams. Open-minded - able to recognize good ideas.
2. Innovative thinker - able to envision new and better ways to do things.
3. Execute complex problem-solving techniques related to design/technical issues. Good instincts and sound judgment for mechanical and structural design.
4. Good understanding of statistical tools and validation/verification techniques.
5. Excellent analytical skills, ability to plan, organize, and implement multiple concurrent tasks.
6. Must be able to analyze and correct complex product and/or process issues and make decisions using independent judgment.
7. Ideally has good knowledge of human anatomy and common surgical procedures.
8. Good working knowledge of CAM/CAE computer systems, engineering materials and design, coating technologies, plastic part design, and advanced manufacturing technologies. Fluent in 3D CAD with good working knowledge of Finite Element Analysis tools.
9. Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing.
10. Must have the ability to work with and assemble small objects and component parts. Ability to operate small hand tools and inspection equipment.
11. Must be able to generate, follow and explain detailed proposals and operating procedures with an in-depth understanding of ISO 13485 and FDA quality system requirements.
12. PC Literate (word processing, spreadsheets, database) and strong knowledge of project management tools is essential.
13. Willingness to travel internationally for live surgery visits and global partner collaboration, and work on international assignments.
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