ADDENDUM:
Engineering/Manufacturing focus
• Experience with design and process FMECA, Process Validation and variability reduction applications.
• Implementation and support of Lean Manufacturing, Demand Flow, Total Quality tools.
• Application of statistical and analytical methods such as SPC, SQC, and DOE.
• Development of manufacturing documentation (MP, IP, BOM).
• Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design).
PURPOSE AND SCOPE:
Ensure that all manufacturing related aspects of the company products are addressed throughout the product development cycle.
The position will work closely with engineering, quality, and manufacturing operations to support the manufacturing of current and
next generation products and improve manufacturing processes.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good
judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in
own area of expertise.
• Develops and maintains the documentation necessary to ensure the consistent manufacture of products (processes,
drawings, and shop floor paperwork).
• Provides engineering support for troubleshooting efforts for any process issues in designated area. Summarizes and draws
conclusions from test results leading to effective technical resolution of process problems.
• Ensures design for manufacturing elements are incorporated into new product development activities.
• Identifies, justifies, and implements multiple significant data driven projects to reduce manufacturing costs, improve
processes, increase product reliability, and enhance process capability.
• Designs and evaluates new and existing fixtures and equipment, test methods, specifications, layouts, and standards.
• Identifies and recommends manufacturing technologies to strategically develop business objectives and potential
opportunities.
• Collaborates with manufacturing staff and management in other disciplines to develop, evaluate, and improve
manufacturing methods.
• Conducts in-depth research to develop and introduce improved manufacturing methods. Analyzes assembly processes to
ensure quality results are achieved and sustained. Analyzes data to determine return on investment.
• Works with production personnel, suppliers and contract manufacturers to establish or revise work instructions and
production procedures.
• Ensures quality outcomes in device manufacturing areas by working with suppliers, quality systems, procurement and
sustaining engineering.
• Performs hazard analysis on new equipment and systems to insure safe working conditions.
• Establishes validation protocols related to assembly and test processes.
• May escalate issues to supervisor/manager for resolution, as deemed necessary.
• Mentor other staff as applicable.
• Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and
federal laws and regulations.
• Assist with various projects as assigned by a direct supervisor.
• Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum
for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
• The physical demands and work environment characteristics described here are representative of those an employee
encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
• Occasionally lift and/or move up to 25 pounds with assistance.
• Travel may requirement up to 10%.
SUPERVISION:
• None
EDUCATION:
• Bachelor's Degree required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
• 5 - 8 years' related experience; or a Master's degree with 3 years' experience; or a PhD without experience; or equivalent
directly related work experience.
• Related experience in medical device preferred.
• Test protocol generation, execution, and reporting.
• Knowledge of current statistical and analytical methods.
• Knowledge of manufacturing documentation.
