Coordinates tooling/process capability studies as required.
Provides technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation, and part transition to manufacturing.
Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices), and custom materials, including supplier validations and the client receiving inspection fixture design for Test method validation Respond with a high sense of urgency to quality issues and escalate/communicate appropriately.
Ensure that Tier 1 suppliers are using capable Tier 2 suppliers for material and outside processing services.
Work with suppliers to optimize processes.
Perform other duties and responsibilities as assigned.
Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable).
Strong documentation, communication (e.g., written and verbal), and interpersonal relationship skills including consultative and relationship management skills.
Basic understanding of statistical techniques.
Previous experience working with lab/industrial equipment required (if applicable).
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Strong problem-solving, organizational, analytical, and critical thinking skills.
Substantial understanding of processes and equipment used in assigned work.
Good leadership skills and ability to influence change.
Knowledge of applicable FDA regulations for the medical device industry.
Strict attention to detail.
Ability to interact professionally with all organizational levels.
Ability to manage competing priorities in a fast-paced environment.
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.
Education and Experience:
Bachelor's Degree in Engineering or Scientific field with 4 years experience including either industry or industry/education OR Master's Degree or equivalent in Engineering or Scientific field with 3 years experience including either industry or industry/education OR Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education.