Sr. Manager, Manufacturing Engineering - Cardiac Surgery, Wayne, NJ

Getinge•Wayne, NJ

43d•$165 - $180

About The Position

Provide support to manufacturing as needed to resolve production issues, evaluate new suppliers and components, and improve manufacturing operations. Lead in design for manufacturability efforts, continuous improvement, and automation initiatives.

Requirements

7 – 10 years manufacturing and/or process engineering experience required.
3 - 5 years’ experience in progressive leadership roles. Experience in medical device or other FDA regulated industry is preferred.
This position requires a bachelor’s degree in electrical, Mechanical, Industrial/Manufacturing or Biomedical Engineering or other related technical degree.
3 - 5 years of direct experience with Lean project design and implementation in a manufacturing environment.
3 – 5 years of direct experience with Automation project design and implementation in a manufacturing environment.
At least two years of direct or indirect P&L management experience
3 – 5 years of direct experience performing technical investigations to support regulatory requirements for manufacturing
Direct experience with process optimization projects yielding improvements in quality and/or cost of manufacturing
Direct experience managing Daily Management Practices in a manufacturing environment
Direct experience in supporting Regulatory audits for manufacturing
Direct experience with NC/CAPA ownership through closure with effective results
Direct experience with successful manufacturing loss improvement initiatives
Must demonstrate effective listening, verbal and written communication, sound judgment, be well organized, take initiative, be flexible, work well under pressure, work effectively with both employee and management and be able to facilitate resolution of complex issues.
Leadership ability in initiating and influencing, coaching, and developing professional technical staff is required.
Proficiency with Microsoft Office Products such as Word, Excel, Power Point and Project Manager or equivalent software applications is preferred.
Position requires strong evaluation skills, the ability to be a self-starter and keep pace in a fast-moving high growth organization.

Nice To Haves

Experience in medical device or other FDA regulated industry is preferred.
Previous working knowledge of SAP or equivalent is highly desirable.

Responsibilities

Implement process improvements and cost reduction plans to achieve sales, complaint, and cost savings targets.
Conduct and manage complex engineering and technical support projects, lead and initiate process and equipment improvements which improve quality and reduce the costs and time to manufacture products.
Lead the development of project plans including the proposed technical approach, budget, and key milestone completion dates for all assigned projects. Initiate appropriation requests for projects.
Drive and direct lean manufacturing practices in all phases of product handling and manufacturing.
Manage projects by tracking progress, assigning staff, and coordinating activities to ensure timely and cost-effective project completion in accordance with established objectives.
Work closely with other functional areas to identify and lead the development of technical approaches for improvement opportunities.
Manage engineering and equipment technician professionals and complex/critical manufacturing processes.
Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.
Lead and ensure all process changes/improvements are appropriately validated and documented to ensure compliance with all regulatory requirements.
Manage departmental budgets, control expenditures to stay within spending limits.
Provide planning, direction and coordination for technical activities associated with the production of Cardiac Surgery products while achieving optimum use of staff, machines, materials, and facilities