Principal Advanced Manufacturing Engineer

Description

Lead design transfer out of R&D. Develop, implement and improve manufacturing capabilities. Assist Manufacturing capabilities in productivity, product quality and cost through the development and implementation of novel and effective methods, tools, equipment, and processes. 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.

• Provide best-practice leadership within 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.
• Establish best practices and author manufacturing procedures; develop Bills of Material.
• 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, assigned technicians and tool room personnel.
• 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.
• Supervise production of consumables and hardware: schedule production to meet demand; build, test, package and label finished goods. Coordinate sterilization with Quality Assurance function. Coordinate distribution with the Supply Chain function.
• Maintain factory GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA   regulations
• Ensure that all regulatory and internal policies are followed

Requirements

• Requires a minimum of 10-15 years’ related experience
• Demonstrated experience with complex electro-mechanical and/or opto-mechanical products and manufacturing processes is required, low to medium volume is preferred
• Demonstrated experience with disposable or single-use devices is preferred
• 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 lower-level personnel. Must be competent with Word, Excel, Project, Power Point applications.
• Experience with Design of Experiments and statistical analysis packages.

Education Requirements

• Requires a Bachelor/Master’s degree (or equivalent) in engineering or related discipline 
• Six Sigma, Black Belt Certification is a strong plus 

Supervisory Responsibility  

Lead a small team of Manufacturing Engineers

Working Conditions 

This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms. 

Physical surroundings 

This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. Manufacturing & laboratory environments require the use of electrical and mechanical equipment and tools. 

Physical Effort 

While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, manufacturing tools, equipment, products, and systems; reach with hands and arms; talk and hear.  

Work Schedule / Travel 

In-person, Monday to Friday; occasional travel of 10-5%. Occasional presence at other locations to include Gardner, MA & Portland ME 

Other Requirements  

Applicants must have US citizenship or US person status.