Senior Process Development Engineer

JOB TITLE

Senior Process Development Engineer

MAIN PURPOSE OF JOB AND OBJECTIVES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Provide Engineering support to improve quality and efficiency for existing components.

Determine critical component and supplier changes to support business needs.

Lead and manage key process items to bring new components through the design phase into efficient manufacturing operations.

KEY DUTIES

• Work with key suppliers to identify and develop improvements to ensure quality and cost requirements.
• Responsible for component qualification activities and improvements
• Design advanced tooling and fixtures that will be used for the manufacturing and assembly of products.
• Develop fixtures, jigs, and gages to assist with component inspection processes.
• Document methods for inspection processes.
• Document evaluations into Engineering Notebooks
• Design, evaluate, implement, and monitor processes and operating systems for the manufacture of aortic stent grafts.
• Develop and implement new Mfg. processes, execute process validations such as IQ, OQ, PQ protocols and reports.
• Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
• Work with Research and Development to develop and transfer new component designs to manufacturing.
• Perform statistical analyses on data groups.
• Present data and projects to upper management when required.
• Lead TMVs and software validation as necessary.
• Monitor and improve the efficiency, output, and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel.
• Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc.
• Create change requests within the company’s change management system.
• Other various responsibilities and projects, as necessary

DIMENSIONS & LIMITS OF AUTHORITY

COMPANY

REQUIREMENTS

.

• Must work within requirements of company handbook and policy statements.
• Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
• always Work within the QMS, ensure accurate completion of records, and highlight issues to immediate supervisor any issues affecting quality.
• Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

EH&S REQUIREMENTS

• Take care of your own health and safety and that of others who may
• be affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

QUALIFICATIONS & EXPERIENCE

Minimum requirements for the position:

• Must work well under pressure.
• Knowledge of AutoCAD and SolidWorks or other CAD modelling software.
• Knowledge of engineering statistics and advanced data analysis
• Strong technical writing skills for manufacturing instructions, test methods, protocols, reports, etc.is a must.
• Able to work closely with a variety of people and teams within the company.
• Ability to organize and conduct experiments independently.
• Ability to analyze and solve technical problems.
• Hands on abilities to engineer tooling, processes, and equipment.
• Hands on experience building prototypes, tooling, and fixtures.
• Excellent written and verbal communication skills
• Proficient in software applications.

Minimum Knowledge & Experience required for the position:

• 4 - year engineering degree or equivalent experience or 12+ years of experience in a technical role in the medical device industry bachelor’s degree in engineering/science and a minimum of 5-year experience in the medical device industry or technical degree/certificate with appropriately 12 years equivalent technical experience in the medical device industry Project management experience in the medical device industry
• Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).
• Project management experience in the medical device industry
• Experience with polymers, medical grade metals and medical packaging.
• Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes