Develop manufacturing processes for new products and modifications to existing ones.
Create fixtures and tooling necessary for the manufacturing process.
Execute process validation protocols (IQ/OQ/PQ).
Analyze process data to enhance process capability and Design for Manufacturability (DFM).
Conduct Installation Qualification (IQ) equipment protocols and prepare related reports.
Evaluate the advantages and specifications of capital equipment and justify capital appropriation.
Maintain accurate documentation including concepts, designs, tool drawings, and shop orders in collaboration with Quality Assurance and R&D departments.
Offer engineering support to production for troubleshooting and resolving technical issues.
Communicate with suppliers to address component and raw material concerns.
Assist manufacturing and quality teams in addressing Non-Conforming Material Report (NCMR) issues.
Manage projects in alignment with business objectives.
Contribute to the company's intellectual property through invention and patent applications.
Stay updated on medical, technical, and biomedical advancements relevant to company products.
Support prototype and pilot production efforts for new products, modifications, and enhancements.
Collaborate with product development to ensure designs are manufacturable and resolve any associated issues.
Maintain compliance with Good Manufacturing Practices (GMP) pertaining to Document Control, R&D, and Quality Assurance.
Uphold company policies, procedures, and regulatory requirements, including FDA regulations.
Provide coaching and mentorship to engineers, assisting in their development.
Identify and mitigate hazards associated with process Failure Mode and Effects Analysis (FMEA).
Fulfill other duties as assigned by supervisor.
Qualifications:
Exercise judgment within established practices and policies.
Proficiency in using moderate to advanced statistical techniques for data analysis and decision-making.
Knowledge of statistical tools like Minitab, JMP, or equivalent.
Familiarity with Solid works or other CAD software (preferred but not required).
May establish methods and procedures for new assignments and offer guidance to junior staff.
Address complex problems requiring in-depth evaluation of various factors.
Education:
Bachelor of Science degree in Engineering or a related technical field.
Experience:
Five years of relevant experience with a Bachelor's degree, or three years with a Master's degree.