Job Description

JOB TITLE

Process Development Engineering Manager

DEPARTMENT

Process Development

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.

Determine operations to produce products and develop processes to ensure quality, cost and efficiency requirements. Lead and manage key process items to bring new products through the design phase into efficient manufacturing operations. Support design transfers from research and development, executing equipment instillation and process validations. Lead, manage, and support product transfers/duplication to other manufacturing sites.

KEY DUTIES

• Lead Process development for existing and new products.
• Lead New product introduction engineering support for new devices.
• Lead the design transfer phase including product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc.
• Lead the conversion of small-scale processes into commercially viable large-scale operations.
• Work with Research and Development to develop and transfer new designs to manufacturing.
• Lead TMVs and software validation as necessary.
• Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc.
• Establish departmental objectives, organization, equipment, and tooling resources and required technical direction.
• Lead cross-functional teams in continuous improvement.
• Recommend modifications/improvement where advisable to minimize cost.
• Develop and maintain yearly departmental budget (Capital & Expense Accounts)
• Provide primary direction for Quality System implementation, maintenance, training, and facilitation for compliance to quality system requirements for manufacturing and engineering staff.

DIMENSIONS & LIMITS OF AUTHORITY

COMPANY

REQUIREMENTS

Must refer to relevant company handbook/policy statements detailing company procedures regarding employee conditions and benefits.

Authorization of purchase orders is given in Authorization of Limits produced by Finance Department

QUALITY

REQUIREMENTS

Ensure compliance with all quality systems regulatory requirements such as, but not limited to, ISO 13485, 21 CFR Part 820, MDSAP, MDD (93/42/EEC) and MDR (EU 2017/745)

Responsible for addressing issues within the QMS without undue delay as evidenced by on time completion of actions on the Single Action Tracker (SAT)

EH&S REQUIREMENTS

Create a safety culture and safe working environment.

Ensure compliance with all Environmental Health and Safety regulatory requirements.

Provide recourse to meet Environmental Health and Safety goals.

Maintain defined organization Environmental Health and Safety competencies.

Ensure related Risk Assessments are completed, accidents raised and action hazards.

QUALIFICATIONS & EXPERIENCE

Competencies

• Applies business understanding.
• Technical leadership and demonstrated success in a broad range of core competencies applying specialized technical skills.
• SME in the application of cross-functional and external resources to departmental activities
• Subject matter expertise in QMS and other requirements
• Communicates effectively.
• Strong cross-functional communication leadership skills
• Preparation and delivery of effective presentations to Executive leadership
• Effective organizational "presence" in communications
• Demonstrates customer focus.
• Provides organizational leadership in applying understanding of industry responsibilities to internal/external customers being supported.
• Develop self and others.
• Demonstrated application of industry skills with defined subject matter expertise
• Recognized mentor to lower positions.
• Drives improvement, innovation, and changes.
• Functionally recognized innovative thinking and relied upon to advance product or process opportunities and solve complex problems and challenges.
• Leads organizational change and improvement opportunities.
• Takes accountability for results.
• Completes individual and leads large project teamwork activities as assigned demonstrating ability to effectively manage overall productivity and deliver strong results.
• Develops effective objectives and executes approaches and timelines to meet or exceed them.
• Teamwork to achieve a common goal.
• Excellent leadership and communications skills with ability to organizationally collaborate effectively with others.

Minimum Knowledge & Experience Required for the Position:

• Bachelor’s degree in engineering/science and a minimum of 7 years’ experience in the medical device industry, experience managing others or leading a team.
• Ability to organize and conduct projects and work independently.
• Ability to analyze and solve problems.
• Good oral and written communication skills (English)
• Working knowledge of an ERP software such as SAP, Oracle, or JD Edwards, etc
• Experience with Lean Six Sigma implementation and support.
• Understanding of quality system regulations (ISO13485, 21CFR820)

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