The Position: Senior Manufacturing Engineer
Department: Manufacturing Engineering
Reports to: Director of Manufacturing
Position Summary: Lead design transfer out of R&D. Develop, implement and improve manufacturing capabilities. Contribute to product design improvements intended to achieve higher reliability, serviceability, and manufacturability. Train technicians and manufacturing personnel on manufacturing equipment operation, procedures and inspections.
Essential Duties and Responsibilities:
- Work with product development staff to ensure that products under development are optimally manufacturable that may include but not be limited to mechanical assembly/dimensioning/tolerances, electrical wiring, materials selection and fabrication methods.
- Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost.
- Perform Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), and DOEs.
- Write manufacturing procedures.
- Investigate benefits and features of capital equipment and generate capital appropriation justifications.
- Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions.
- Provide engineering support to production department in troubleshooting and resolving technical problems.
- Coordinate work with outside vendors.
- Plan and schedule projects in a manner consistent with corporate objectives.
- Support prototype and pilot production of new products, product changes, and enhancements in coordination with the R&D, Manufacturing and Quality Control functions.
- Supervise the complete, accurate, and timely preventive maintenance of equipment and tooling.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
- Ensure that all regulatory and internal policies are followed
Education, Training, Skills and Experience Requirements:
- Requires a minimum of 5 years related experience.
- Requires a Bachelor/Masters degree or equivalent in engineering or related discipline.
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- May determine methods and procedures on new assignments and may provide guidance to other personnel.
- Must be competent with Word, Excel, Project, Power Point applications.
- Experience with Design of Experiments and statistical analysis packages.
- Six Sigma, Black Belt Certification is a strong plus.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time.