Head of Manufacturing Engineering & Process Development

Job Overview

The Head of Manufacturing Engineering & Process Development leads initiatives to mature medical device products from prototype to market through scaling of assembly processes and influence on device design to ensure DFM. This role collaborates closely with the NPI Leads and on a global cross functional level with project stakeholders to define a competitive manufacturing strategy.
Leads the manufacturing engineering team in successful execution and development. The Head of Manufacturing Engineering & Process Development develops the process strategy to move the product from development stages to mass manufacturing, coordinating, planning, and managing the activities related to the production process according to the lean six sigma methodology. 

Responsibilities

• Lead and manage the manufacturing engineering team, providing guidance, mentoring, and training to ensure the team's success and professional growth.
• Wide knowledge and experience on engineering technologies to support prototype through high volume manufacture including: fixture design, material handling, bonding technologies, QC methods, application methods, packaging, etc.

• Lead expert of advanced work on multiple assembly technologies (e.g. laser welding, ultrasonic welding, heat staking, sensors, robotics, vision systems, etc.)

• Capable to resource, delegate, constructively critique, and monitor technical work to satisfy packet objectives

• Collaborate with cross-functional teams, including design engineering, production, and quality assurance, to develop and implement new products or processes.

• Develop and implement manufacturing processes and procedures to optimize production efficiency, quality and safety 

• Capable of identifying risks of inability to meet targeted COGS, and champions solutions to recover

• Manage and oversee the implementation of new equipment, technologies, and automation systems to enhance manufacturing capabilities and efficiency

• Ensure the technological and manufacturing strategy alignment between R&D, PD and Operations

• Collaborate with suppliers and vendors to source and evaluate new technologies, materials, and equipment to improve manufacturing processes and reduce costs

• Planning and implementation of measures to fill technical gaps/risks or failures within the organization

• Provide technical support and guidance to resolve complex manufacturing issues, troubleshoot problems, and optimize production output.

• Responsible for the final mfg documents such as but not limited to: BOM, Work instructions, test plans, V&V reports, PFMEAs, Engineering Change Orders, IQ, OQ, PQ etc.

• Assists EH&S as needed, and champions a safety first process and team culture

• Collaborates with Manufacturing site(s) to proactively plan for and support product transfer

• Leverage lean methodologies, business acumen, and critical thinking to effectively scale and process improve workflows

• Champions company vision and culture 

What your background should look like:

• Bachelor’s Degree in Engineering, Manufacturing or equivalent preferred Experience, Master’s degree preferred
• Designed, Maintained, Scaled, and Improved production lines
• Worked within an ISO 13485 regulated environment
• Minimum of 5-7 years of experience Skills industrializing production lines
• Strong team player
• Strong understanding of manufacturing transfer
• Manage customer relationships
• Strong problem solving, judgement and decision-making skills
• Strong organizations skills and ability to solve ambiguous situations internal and external to the company
• Proficiency in MS Word, Excel, PowerPoint
• Excellent communication skills with the ability to speak effectively before groups of Team Members. 
• Thrives in a constantly changing business environment.
• Strong leadership skills with the ability to lead cross-functional teams

Competencies