- Job Title: Engineering Extrusion Manager – Medical Device Extrusion
- Company: Biomerics ATL
- Location: Indianapolis, IN
- Salary: D.O.E.
- Please read the job description carefully and only apply if you have the stated technical requirements
Company Overview: Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in the design, development, and production of medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for the vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets. Please explore our website for more information about our offerings and capabilities.
At Biomerics, we are dedicated to our employees, because we understand that a strong, skilled, happy workforce is the foundation of a successful business.
Job Description: Extrusion Engineering Manager manages and directs Extrusion Engineering business unit for the Biomerics CRI business unit. The priorities for this position include implementing product and process improvements, strategic planning, product design, quality assurance and problem resolution. The Extrusion Engineering Manager must execute customer product support initiatives to meet company objectives, partner with the customer and management, and develop systems and controls to ensure compliance with quality standards. This business unit has two locations and international travel is required. Current product lines are mechanical assemblies that are often extrusion-based, or tube sets for the contrast media management and anesthesia sectors.
- Develops and drives strategies and methods to achieve the highest levels of quality and reliability in product development.
- Develop and drive project plans by identifying tasks, resource requirements, time lines, and capital and expense budgets, coordinate the selection and qualification of new capital equipment and cost improvement projects for manufacturing.
- Develop and implement new tooling, fixtures, procurement, installation, start-up, process improvements, product processes.
- Perform cost improvement projects and quality improvement projects to reach manufacturing goals.
- Responsible for ensuring proper documentation consistent with company’s quality system
- Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives
- Apply engineering knowledge and managerial skills to design and develop new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost
- Estimate staffing requirements and skills needed to complete projects on time and within budget
- Responsible for Good Manufacturing Practices, International Compliance Standards, and company procedures
- Responsible for medical industry required validation and documentation.
- Provide leadership, goal setting, communications, and facilitation skills as needed to guide and motivate project personnel
- Assure appropriate training and skill development is furnished to engineering staff as needed
- Provide input to company strategic and long-range business plan, and ensure that development projects further these goals.
- Support and oversee polymer synthesis, compounding and extrusion from the initial chemical components to finished extruded products.
- Maintain a safe work environment.
- Assist in the development of customer specifications and translating into detailed engineering specifications, including material selections, dimensioning, tolerance and assembly requirements
- New product testing, including comparison testing with competitor products, protocol and test report documentation
- Responsible for overall verification efforts and project documentation
- Participate in Design Reviews
- Responsible for compliance with QSR Design Control
- Management of engineering budget and ensures current and accurate costing (including specials) in conjunction with finance
- Ensure full compliance to quality systems and financial requirements including the development of procedures to address these areas and ensuring full compliance of the teams under this role’s direction.
- Manages and builds current Bill of Materials (BOM)
- Ensure DRM (Design for Reliability & Manufacturability) through application of predictive engineering methods with the design innovation to ensure product design robustness and execution cost effectiveness, as well as manufacturability.
- Recommends methods, materials and layouts for improvement based on manufacturing needs and capabilities
- Builds, develops and manages engineering team capable of carrying out needed engineering initiatives
Skills and Abilities:
- Must have experience working through all aspects of medical device design and development including design Verification / Validation and Process Validation / Technology Transfer
- Previous experience in development of complex medical devices is required
- Extrusion subject matter expert
- Experience with ISO/CE certification
- Working knowledge of current FDA Quality Systems Regulation, emphasizing Design Control
- The ability to lead a team toward operational objectives with aptitude to contribute to strategic goal-setting for department/business unit
- Possesses a willingness to provide coaching and instruction to managers and employees
- Excellent judgment and creative problem-solving skills including conflict resolution skills
- Strong interpersonal and organizational skills and the ability to work effectively as a team member
- ands-on approach to product development
- Simultaneously handles a wide range or projects and a broad array of responsibilities
- Superior management skills; ability to influence and engage direct and indirect reports and peers
- High level of mental stamina, adaptable, collaborative, and proactive
- Exceptional written, oral, interpersonal, and presentation skills
- Ability to apply analytical skills and scientific technical principles in problem solving and development
- Ability to operate as an effective tactical as well as strategic thinker
- Proficiency in Microsoft Word, Excel, Project, PowerPoint and SolidWorks is required
- Excellent leadership and motivational skills
- Must be fluent in English and Spanish
- Ability to travel to Costa Rica on a routine basis
Education, Training and Experience:
- Bachelor’s degree in Engineering or related field of study (Mechanical, Materials Science, Plastics, etc.)
- Five or more years of experience in progressive technical, engineering, quality and/or manufacturing leadership roles in related Medical Device OEM Industries.
- Five or more years of Medical Device Plastics Extrusion experience
- Five or more years of proven leadership experience with a Medical Device Original Equipment Manufacturing Company running multiple projects simultaneously.
- Proven track record of success facilitating progressive organizational change within a growing OEM Medical Device organization.
Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k
Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted)