Manager, Engineering

Overview

The Manufacturing Engineering Manager leads a manufacturing engineering team responsible for sustaining, improving, and scaling robust manufacturing processes for neurovascular products in a regulated medtech environment. The role ensures compliance with site quality systems, EU MDR, ISO 13485, and FDA 21 CFR Part 820/QMSR requirements while driving NPI transfer, validation, automation, capital deployment, and continuous improvement.

Responsibilities

• Lead and manage a manufacturing engineering team, including performance management, prioritization of resource assignments, recruitment, mentoring, and supervision.
• Champion employee relations, communication, and a culture of inclusiveness, trust, and teamwork.
• Set performance targets for the value stream and measure actual performance against product quality, customer service, department spending, labor efficiency, and yield.
• Identify, interpret, and act on performance trends, taking corrective action when needed.
• Provide leadership and direction on process improvements, resolve obstacles, allocate resources, and collaborate with cross functional teams.
• Develop and maintain a world class manufacturing group proficient in process improvement and problem solving using Six Sigma tools.
• Drive Integrated Business Plan (IBP) contract deliverables by providing input on process technology selection.
• Collaborate with R&D partners to ensure new products and processes are introduced into production on time, within budget, and operationally successful.
• Manage departmental budgets and capital spending approvals.
• Represent the function in periodic business metric reviews and lead cross functional partnerships to resolve production and engineering issues.
• Ensure out of hours support to the business as required by shutdowns, projects, quality issues, and equipment failures.
• Interface with other business functions, third party vendors, suppliers, and sister sites to support day to day operations.
• Maintain relationships with technical management in sister sites and R&D to support continuous improvement.
• Oversee specification and purchase of capital equipment, balancing technological capability and return on investment.
• Plan and execute process and equipment validations per company requirements.
• Travel to other sites up to 10% of the time.

Qualifications

• Degree or Master's in a relevant engineering or science discipline (Manufacturing, Mechanical, Electronics, Production, etc.).
• Minimum 10 years of relevant experience in a team based regulated manufacturing environment, with at least 5 years at a senior/management level.
• Good knowledge of GMP/FDA regulatory requirements and current health & safety legislation.
• Proven track record delivering manufacturing performance improvements in yield, scrap, cycle time, quality, capacity, and cost.
• Strong analytical, problem solving, and stakeholder management skills; Lean/Six Sigma experience preferred.
• Strong leadership skills, confident decision maker, capable of negotiating and influencing others.
• Excellent presentation and written and verbal communication skills.
• Team player with a flexible approach and ability to work autonomously.
• Willingness to source, investigate, and implement technological and automation advances on the floor.