Job Description

Job Title: Director of Process Manufacturing

Location: United States (30% travel)

Job Type; Full Time, Permanent

Skills Alliance are partnered with a global medical device manufacture that are seeking an experienced engineering leader to oversee the design, deployment, and optimization of manufacturing processes and equipment in a regulated, high-precision medical device environment. This role is pivotal in ensuring that manufacturing systems meet stringent quality, compliance, and efficiency standards, while supporting global operational and business goals.

Key Responsibilities:

• Lead the strategic development and implementation of scalable, compliant, and cost-effective manufacturing processes and equipment used in the production of medical devices.
• Collaborate closely with product development teams to ensure manufacturability, cost-of-goods targets, and regulatory compliance are embedded early in design.
• Ensure all equipment and processes align with medical device regulatory requirements (e.g., FDA, ISO 13485), including validation protocols, risk analysis, and traceability.
• Oversee capital equipment projects from concept through qualification (URS, FAT/SAT, IQ/OQ/PQ), ensuring timely execution and alignment with facility and production readiness.
• Drive design for manufacturability (DFM), design for assembly (DFA), and ergonomic operator considerations across all process solutions.
• Partner with Quality, Production, Maintenance, and Procurement functions to ensure robust process controls, equipment reliability, and sustainable supplier relationships.
• Manage a team of engineers and technicians across multiple sites, fostering continuous improvement and technical growth.
• Analyze and improve existing manufacturing systems through upgrades, retrofits, or complete redesigns to meet new product and regulatory demands.
• Own capital planning and execution, with high accountability for forecasting accuracy and return on investment.
• Implement Smart Manufacturing technologies to enhance data visibility, traceability, and operational efficiency.
• Serve as the technical lead during manufacturing challenges, product launches, and site readiness activities.
• Maintain full compliance with corporate quality systems, environmental health & safety standards, and relevant medical device regulations.

Qualifications:

• Bachelor’s degree in Mechanical, Biomedical, or Industrial Engineering; advanced degree (MS, MBA) preferred.
• 10+ years of engineering leadership in medical device or other highly regulated manufacturing environments.
• Demonstrated success in process design, capital project execution, and cross-functional leadership.
• Deep understanding of medical device quality systems, risk management (FMEA), and validation requirements (IQ/OQ/PQ).
• Experience with advanced manufacturing tools including CAD, PLM systems, simulation software, and Smart Factory technologies.
• Proven ability to lead global teams and manage complex, multi-site programs with high business impact.
• Willingness to travel domestically and internationally up to 30%.

Please reach out to emily.james@skillsalliance.com for further information.

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