Engineering Manager, Interventional

Overview
About Cretex Medical
Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.
Manufacturing Engineer Manager-Interventional Position Summary
The Engineering Manager- Interventional, will be responsible for leading and developing the engineering staff and establishing manufacturing of extruded medical tubing, braid & coil components. Must be able to specify equipment and facility needs, work with equipment manufacturers and material suppliers to implement a foundation for Cretex Medicals extrusion business. As equipment is installed, work directly with cross functional team to identify insourcing opportunities as well as work with customers to develop new opportunities that would support the companys foray into catheter manufacturing. Knowledge of braiding, coiling, reflow and other catheter assembly technologies is highly valued in this role.
Responsibilities
Duties and Responsibilities

– Manage all customer component projects through the project management system with the engineering staff through pre-production process; design for manufacturability, and execution of all engineering tasks throughout the manufacturing process
– Specify equipment, facility needs, draft capital expenditure proposals & coordinate purchase of equipment for Cretex Medicals extruded tubing, braid & coil technologies.
– Manage technical reviews and design for manufacturability with our customers and internal engineering departments
– Perform necessary acceptance activities for new equipment, ensuring it is capable of meeting performance requirements and subsequently capable of production quality output
– Primary technical owner for new extrusion opportunities from R&D phase through NPI and into sustained production.
– Design and develop repeatable manufacturing processes for high precision polymer extrusions.
– Independently troubleshoot process, equipment, and material challenges.
– Support adjacent technologies or capabilities in catheter assembly as necessary, such as braiding, coil winding, polymer reflow, catheter tipping, and such.
– Initiate and complete technical activities leading to new or improved processes or design for manufacturability for current and next generation programs and to meet strategic goals and objectives of the company.
– Lead process improvement and Operational Excellence within the engineering department
– Manage and review quoting activity for interventional components (extrusions, braid & coiling) ;manage projects to be within the quoted budged and meet the on-time delivery goals
– Lead a team including: identifying key talent needs, hire personnel to support and scale the business and meet customer demand and business need.
– Manage work hours, vacation requests, review performance, discipline, terminate, compensation changes, and ensure compliance of personnel to corporate policies for direct reports.
– Provide employees with goals, performance initiatives, and areas of accountability that are directly aligned with the goals of Cretex companies; train and develop Engineers and Technicians and create/utilize engineering standards

Requirements

– Bachelors Degree in an Engineering Science
– 5 years of direct experience in polymer extrusion
– Previous team leadership experience; ability to follow through on commitments and hold team members accountable
– Project management experience, ability to manage internal and external relationships
– Engineering experience with medical device or medical device component manufacturing; manufacturing process knowledge
– Experience in an ISO13485/FMP environment; knowledge of Quality System: ISO9001, ISO13845
– Experience with resin and extru ion management (e.g. handling, storage, moisture management, heat history)
– Manufacturing process design, validation, equipment and fixture/gauge design
– Lean manufacturing experience; ability to solve problems and root cause analysis; team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)
– DOE, SPC, FMEA, GMP, QSR; knowledge of statistical software
– Manufacturing automation, including electronic visual inspection
– 3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.)

Manufacturing Engineer II Preferred Knowledge, Skills and Abilities

– Continuing Education; including participation in local chapters, associations, and/or organizations

Qualifications
What is it like to work at Cretex Medical?
We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.
Here are some of things that employees have said about working for Cretex Medical:
“The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.”
“I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.”
“I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.”
We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.
Company Benefits
Cretex Medical offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. Cretex Medical also offers a 401(k)-retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off and holiday pay.
Cretex Medical also offers company-specific benefits, such as:

– Employee Appreciation events
– Volunteer Opportunities
– Training and Development opportunities
– Tuition Reimbursement

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.
Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.