Engineering Manager

Job Description:
The Engineering Manager, Medical Tubing and Film provides day to day guidance, direction, pace and accountability for the Engineering Department focused on Medical Tubing and Flexible film extrusion and converting processes.  Manages various engineering activities including safe plant operations, new product/process development, capital equipment projects, manufacturing standards and training, continuous improvement, and other sustaining operational activities. 

The ideal candidate for this role is a technical leader with a proven track record of maximizing the business impact of teams, investing in developing talent, and jumping in with a hands-on approach to drive new product and process excellence.

ESSENTIAL DUTIES:

• Actively promote and drive a culture of safety within Spectrum Plastics.
• Develop and maintain a diverse, well-trained, high energy, motivated engineering team by setting expectations, goals, and direction and providing training, mentoring, coaching, recognition, and feedback
• Manage and drive all facets of engineering projects including design, construction, automation, assemblies, process development, validation activities, documentation, training, and transfer to production.
• Drive continuous improvement activities using Lean Manufacturing methodologies to improve both the efficiency and quality of manufacture with strong accountability for site savings goals
• Establish and manage project schedules, delivery dates, and cost objectives.  Drive engineering team to execute on these plans.   Communicate this information to internal and external customers.
• Interacts with internal and external customers, by meeting regularly and responding to requests
• Drive capital investments including resourcing, budgeting, and execution of capital projects.
• Apply risk management best practices to the development and manufacturing processes by identifying hazards, estimating and evaluating associated risks, controlling these risks, and monitoring the effectiveness of risk controls.
• Generate and keep all manufacturing documentation up to date (BOM’s, specification changes, ECO’s, reports, print revisions, fixturing, protocols, etc.).
• Discover and explore new business opportunities, unmet customer/market needs, and technology opportunities to fill the pipeline.
• Support the commercial teams by providing customer support as the go-to technical leader for extrusion and films in medical applications.
• Define and manage project activities for commercial release of new products and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations.
• Translate customer needs into quantifiable CTQs that can be used to scope projects, report progress to targets, and create actionable plans to meet customer requirements.
• Collaborate with site operations leadership to identify and resolve technical systemic challenges and support commercial solutions.
• Collaborate and communicate effectively in a cross functional organization. Use strong presentation skills to present technical information to audiences with diverse backgrounds and connect technical concepts to business outcomes.
• Available to travel domestically or international as needed up to 15%

• Bachelor’s degree in Engineering with 8 years of related experience or equivalent
• Industry experience in polymer extrusion and converting; medical applications preferred
• 5 years in management/leadership roles
• Strong project management and leadership skills.
• Excellent problem-solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner.

• Track record of being resourceful and innovative to pull together the tools, equipment, and resources, to drive projects across the finish line
• Superior level of customer service and responsiveness.
• Highly collaborative with excellent written and verbal communication skills.
• Ability to manage multiple projects and responsibilities simultaneously.
• Ability to work in a fast-paced, team environment.
• Strong working knowledge of Microsoft Office software.
• Experience as project manager on projects that involved all phases of product design and development, leading cross-functional teams through the execution of project activities
• Demonstrates success developing full-scale project plans
• Effectively communicates project expectations to team members and stakeholders in a timely and clear fashion
• Experience managing financial responsibilities for major programs, such as budget accountability and revenue recognition

Preferred:

• Master’s Degree in Engineering discipline
• High degree of understanding of requirements for medical device manufacturing (GxP, ISO 13485, FDA 21 CFR Part 820)
• Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2)
• Statistical Analysis expertise highly desired (DOE, Lean Six Sigma, minitab, jmp)

WORKING CONDITIONS:

While performing the duties of this job, the employee is regularly required to sit and stand for moderate periods of time in an office and factory setting.  Regular use of hand tools, micrometers, and microscopes is required.  The employee is occasionally required to stoop, will regularly lift up to 20 pounds, and occasionally be required to lift and/or move up to 50 pounds.