Engineering Manager

JOB DESCRIPTION The Site Engineering Manager will lead a team of talented engineers and technicians responsible for providing our manufacturing operations with the vision, technology, and expertise they need through the entire production process. This role will have responsibility for the engineering resources that support medical device manufacturing, packaging, molding, and extrusion. This position is also a member of the Plant Leadership Team (PLT) and will help shape the strategic direction of the business.

KEY ROLE AND RESPONSIBILITIES:

• Reporting directly to the Plant Manager, the Manufacturing Engineering Manager will be passionate about creating a culture of safety, cooperation, and commitment to delivering high quality product on time and at cost.
• Train and mentor engineers in best practices related to validation (IQ, OQ, PQ), and how to perform a successful product line transfer into production.
• Will ensure that our processes are successful in meeting the design requirements and specifications as outline by the customer. May work directly with customers on defining what these requirements should be.
• Create a strong operational excellence and continuous improvement mindset within the engineering organization through the use of LEAN and CI principles/methodologies to optimize performance to quality, delivery, and cost.
• Utilize project management to organize key initiatives and ensure projects are executed on time. Actively work with engineering team to reduce risk and proactively remove roadblocks to ensure deliverables are met. Where appropriate create risk mitigation plans with defined triggers.
• Support the PLT in creating the strategic vision for the site and outlining the improvements goals for the engineering department.
• Manage the funnel of continuous improvement opportunities and create a yearly CI Plan that outlines the cost savings that will be delivered by engineering and other resources within the plant.
• Focus on the development of engineering resources through regular 1on1's, creating a development plan for each engineer, providing opportunities for growth & learning, etc.
• Actively work to break down barriers between functions and departments to improve how information and work flows through the organization. Be willing to constructively challenge yourself, your team, and other functions in the spirit of continuous improvement.
• Develop and mentor a zero loss mindset across critical areas to optimize quality, delivery, and cost while improving safety.
• Drive compliance and improvements to key manufacturing systems such as bill of material (BOM) data integrity, preventative maintenance (PM), calibration, process mapping, etc.
• Lead and facilitate breakthrough Kaizen events.
• Develop and improve problem solving skills and capabilities at all levels of the organization and focus on robust and sustainable corrective actions.
• Drives exceptional communication and customer service skillset by showing a strong mindset and critical thinking skills to address and managing customer concerns or issues.
• Provides input into key plant decisions and resource planning. Will own managing and maintaining the engineering department budget.
• Data driven approach to manage cost and productivity throughout the operation.
• Utilize metrics to track performance and ensure clear accountability to meeting plant operational and financial performance.
• Will ensure production equipment is performing as expected and evaluate new technologies that will better enable us to serve our customers. Evaluate and select equipment to support process upgrades and new product introductions.
• Will lead automation initiatives where applicable to improve quality, drive down cost, and improve capacities.
• Will regularly review and improve our internal processes and procedures to ensure we stay compliant with quality, safety, and other regulations applicable to our operations.

Minimum Qualifications:

• Bachelor of Science in Engineering or related field
• Minimum 8 years related engineering experience in a manufacturing environment
• Minimum 5 years management experience
• Experience in silicone and/or plastics molding / mold design
• Experience in automation design and/or implementation
• Demonstrated ability to manage projects, including silicone and/or plastics injection
• Demonstrated excellent oral and written communication skills
• Demonstrated proficiency in Microsoft Word, Excel, and PowerPoint programs.
• Highly organized with proven time management and prioritization skills
• Demonstrated the ability to handle the pressure of meeting tight deadlines and adapting to rapidly changing priorities

Preferred Qualifications:

• Thorough knowledge of ISO 13485 and FDA Quality System requirements
• Knowledge of financial, sales and marketing as related to development and manufacturing
• Solid understanding of current software, tooling and mechanical engineering issues and needs
• Injection molding and material coatings, medical grade silicon, plastics, extrusion, and final assembly manufacturing.

Physical Demands:

• Occasional lifting to 50 lbs.

Work Environment:

• Some travel may be required