Work Flexibility: Hybrid

Position Summary:

Responsible for creating a work practice, environment and culture that elevates NPI Delivery, Technical Rigour and Manufacturing Process Development throughout the lifecycle of launching new products.

Role success will be gauged by this individual’s contribution in coaching the engineering team to effectively meet and/or exceed new product metrics including product cost, process performance and time to market.

Key Areas of Responsibility:

Own one or more critical manufacturing process development workstreams while supporting the technical direction, objectives, and success criteria for related workstreams across the project.

Ensure technical rigour, governance, and appropriate engineering discipline are applied across own and adjacent process workstreams,
Make informed, data-driven technical decisions across multiple manufacturing process development workstreams.
Monitor, challenge and support process development progress ensuring appropriate application of Engineering best practices, six sigma methodologies, statistical analysis, company procedures and policies.
Coach and mentor other Engineers, on NPI delivery, manufacturing process development, engineering best practices, structured problem solving, Six Sigma, and other function related topics.
Conduct experimental testing and DOEs to determine optimal and robust operating parameters.
Lead manufacturing process development reviews, providing technical challenge, guidance, and direction to ensure high quality engineering outputs.
Partner with tooling, fixturing and equipment suppliers to define, develop, test, optimise and validate manufacturing solutions that meet technical, quality, cost and scalability requirements.
Lead capital acquisition activity from identifying potential suppliers, conducting initial proof of principles, specifying equipment requirements, testing, defining acceptance criteria, and technical approval of equipment readiness.
Contribute to process technology roadmap activities and drive innovation in manufacturing technologies ensuring alignment with future product launches.
Successfully collaborate with cross functional project team members to achieve project, product and operational success.
Lead or provide technical input into PFMEA, Control Plans, SOPs, PPAP documentation, validation documentation, and other launch deliverables associated with new product and process introductions.
Complete capability studies for process control and generate subsequent production documentation ensuring that all activities are completed and documented in accordance with Stryker new product development procedures.
Lead and/or support process qualification activities, including IQ, OQ, and PQ for manual, semi-automated, and automated manufacturing processes. Review and approve validation protocols, reports, and supporting documentation as required.
Provide engineering support for new product and process introductions. Provide training to manufacturing team members and other Engineers.
Promote a culture of technical excellence, structured problem solving, knowledge sharing, and continuous improvement across the engineering team.
Lead and/or provide technical input into the Stryker design transfer process, ensuring robust manufacturing readiness and that internal and external supply chains are set up for successful launch, scale-up, and sustained performance.
Ensure adherence to GMP and safety procedures.
All other duties as assigned.

Qualifications Knowledge Skills:

B.S in Mechanical / Manufacturing / Precision Engineering or related engineering discipline with 6 or more years’ industry experience.
Demonstrated passion for taking on complex technical challenges where there are no obvious answers, and for bringing ideas from concept through to successful launch
Excellent working knowledge of manufacturing processes, inspection equipment, materials, and process design.
Strong understanding of Design for Manufacture, Design for Inspection, and Design for Assembly principles.
Ability to read and interpret complex engineering drawings, with strong knowledge of geometric dimensioning and tolerancing.
Proficient in the application of statistical analysis to manufacturing process development, process capability, and problem solving.
Excellent interpersonal and communication skills, with the ability to clearly express technical ideas, influence cross-functional stakeholders, collaborate effectively to achieve project goals, and remain open-minded to alternative approaches and good ideas.
Innovative thinker with the ability to identify, develop, and implement new and improved ways of working. A continuous improvement and Lean Six Sigma mindset is advantageous.
Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
Strong engineering judgement, with sound instincts for mechanical, manufacturing, and structural design considerations.
Excellent analytical skills, ability to accurately plan, organise and implement concurrent tasks.
Experience working in an FDA-regulated or similarly regulated industry is beneficial.

#IJ

Travel Percentage: 10%

Senior Staff Engineer - Process Development, Advanced Operations

Job Description