Director, Manufacturing Engineering

Director, Manufacturing Engineering

The Director, Manufacturing Engineering is responsible for overseeing manufacturing engineering, integrated manufacturing, new product introduction, manufacturing systems integration, and supplier engineering. This role carries administrative and engineering approval authority for process-related documentation and process changes. The Director is expected to foster a culture of excellence in quality, manufacturing, and innovation to achieve process excellence, maintain long-term competitiveness, and drive future business growth. In addition, the position provides strategic leadership and technical direction to business unit engineering managers, while establishing individual and team goals that ensure the delivery of exceptional performance to both internal and external customers. This leader will have a team of 10+ direct reports and a total organization of ~30 team members.

This leader is required to be based in proximity to Portage, MI and follow an onsite work schedule of Monday through Friday, during regular business hours.

Responsibilities

• Partners with the Continuous Improvement Team to drive culture to support LEAN/CI, change control, validation, etc.
• Develops and executes an engineering strategic plan that aligns with the direction of the organization and associated budget.
• Owns and implements the necessary systems for validation and process development/control at a site level that meets and adheres to FDA QSR, ISO 13485 and Corporate and Divisional procedures and instructions.
• Serves as a key member of the Plant Leadership Team on strategizing and executing plans for product deployment, manufacturing, cost reduction and product/component sourcing.
• Works with R&D to ensure that all new products are designed and optimized for manufacture, that process validations are fully complete and that all related process documentation is in place prior to manufacturing startup and product launch.
• Ensure the application of statistical methods to estimate future production requirements and determine process capability. Ensure that all new product builds achieve performance, quality, cost, yield, capacity and launch attainment goals. Ensure the efficient and timely transfer of process knowledge from engineering to operations.
• Identify, investigate and implement a pipeline of new and advanced manufacturing process and automation technologies and methods, and develop competencies which will enable new and disruptive product designs, enable radical cost reduction, maintain competitive advantage in manufacturing and create new market and growth opportunities.
• Oversee the specification, purchase and qualification of capital equipment ensuring balance between optimizing technological capabilities and return on investment. Will monitor and control progress of projects to ensure sound application of engineering principles are used and design intent is being followed/achieved. Will have a prime role with respect to equipment and process optimization ensuring flawless delivery of all project commitments.
• Partner with the R&D, Supply chain and strategic sourcing team to develop close strategic collaborations with OEM's, component suppliers, manufacturing equipment and technology partners to ensure optimum vendor selection, machine/component pricing and supply chain design.
• Drive the achievement of excellence in project management and communicate regular weekly updates on project status to senior management, project teams, stakeholders and sponsors.
• Ensure that monthly departmental and project budgets are adhered to. Monitor and review of monthly departmental budgets and compilation of overall monthly capital and expense spend projections.
• Partner with Quality and Product Engineering to drive product reliability up and Out of Box Failures to 0. Drive release responsibilities for all engineering functions to ensure CAPA's are resourced appropriately and drive product de-proliferation efforts to optimize our manufacturing.
• Will have periodic contact with customers (e.g. face to face, telephonic, written correspondence, E-mail)
• Responsible for inter-departmental compliance with company policies and corrective actions
• Responsible for the professional and technical development of employees within the assigned areas. Works as a key member of the lead team in driving a culture of talent focus and excellence.

Education/Special Training Required

• Bachelors degree in Engineering required, preferably within Mechanical, Production, Manufacturing or a related specialty area.
• 10+ years of engineering experience in a regulated industry, preferably in medical device, automotive or aerospace
• Prior experience leading a team of direct reports

Qualifications/Work Experience Preferred

• Black belt certified preferred.
• Excellent analytical skills, ability to plan, organize, and implement multiple concurrent tasks.
• Excellent interpersonal and communications skills with an ability to overcome language and cultural barriers.
• Experience in executing complex problem-solving techniques related to design/technical issues.
• Must be able to read and interpret complex engineering drawings and have a good understanding of geometrical dimensioning and tolerancing.
• In depth understanding of ISO and FDA quality system requirements.
• Excellent interpersonal communication, managerial and leadership skills.
• Ability to effectively lead and manage multi-disciplinary teams and plan for the teams' future needs and operations.
• Experience with financial accountability for independent budgets.
• Well-organized and detailed oriented professional, with strong verbal and written communication skills.

Mental Requirements

• Must be able to generate and explain extremely detailed proposals, guidelines and procedures
• Must be able to analyze and resolve complex process development and ongoing support issues of a broad scope using independent judgment
• Must be able to observe and correct minute inconsistencies (e.g. in the printed word, component appearance, etc.).

Physical Requirements

• Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, etc., generally involves sitting most of the time
• Must be able to communicate with large groups of people.
• Must be able to communicate via verbal, written correspondence, telephonic and electronic media (e.g. E-mail)
• Must be able to use common office equipment (e.g. PC, calculator, telephone, etc.).

Travel Percentage: 10% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.