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Manufacturing Process Engineer

A job at Full time
Professional Level Professional experienced
We are looking for As of now
DivisionMedical
Location  Rochester, NY

Where we need you

SUMMARY

Designs and develops manufacturing processes for medical devices, including process development, design for manufacturing, fixture/tool and equipment design, documentation, implementation, problem solving, training, transfer to manufacturing, and hands-on manufacturing assistance.

Working cross-functionally with our customer’s design team and our internal team, the Manufacturing Process Engineer will bring products from design and prototyping through testing, design verification/validation, manufacturing, and post introduction monitoring.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Develop new and improve existing manufacturing processes to produce high-quality medical devices. Use technical knowledge and industry experience to ensure manufacturing processes are capable and “designed for manufacture.”

Plan, conduct and analyze process/product tests to understand variables and interactions. Write engineering reports to document tests, results and conclusions.

Specify equipment and processes to meet customer requirements/specifications. Design and implement new or improved fixtures and tools to support manufacturing processes.

Develop clear process and manufacturing documentation. Train production and set-up personnel.

Maintain relationships with tool vendors and suppliers. Ensure clear communication of specifications and deliverables. Specify and order materials for process development and prototype manufacturing.

Utilize six-sigma quality tools, when appropriate, to define, measure, analyze, improve and control processes and outcomes.

With Quality Engineering, participate in protocol development and execution of equipment IQ and process validations (OQ/PQ) per applicable internal and external procedures/standards.

Lead projects as requested pertaining to process development, fixture development, and/or equipment implementation.

Maintain communication with manufacturing on established products concerning changes, revisions, problems and take necessary action.

Establish and maintain open communications and productive relationships with individuals in all levels of the organization, customers and suppliers. Provide status updates and ongoing communications to suppliers, internal colleagues and customers.

Enforce and contribute to a culture of safety and GMP compliance through technical specifications, training and awareness of standards and regulations. Comply with FDA, ISO and internal QSR requirements

How to convince us

EDUCATION AND EXPERIENCE

Bachelor’s degree (BS) from four-year college or university and a minimum of five years related experience and/or training; or equivalent combination of education and experience.

Experience developing manufacturing processes for medical devices. Preferred experience with injection molding, small part manufacture, welding and stamping.

Preferred experience in mold tooling and design, machinery, assembly fixtures, equipment and tooling procurement and design

Experience in Medical Device (ISO13485), Pharmaceutical GMP environments.

Knowledge in design and operation for 3-D printing of holding fixtures, tool fixtures, and other simple to moderately complex devices.

SKILLS AND ABILITIES

Strong engineering/process development skills with hands-on mechanical aptitude.

Utilizes disciplined, methodical approach to problem solving with an urgency to understand the problem and see it through to resolution.

SolidWorks or similar CAD program to sketch-out and design fixtures and electro mechanical systems.

Excellent verbal and written communication skills to technically and professionally describe test scenarios, deviations, non-compliances and risks.

In the Medical division, you will work with our customers to make pioneering contributions to disease prevention and health restoration worldwide. We offer a wide selection of custom-tailored components through to complete systems.

In the Röchling Group you’ll be shaping industry. Worldwide. Together, we are changing everyday lives – by making cars lighter, making drug packaging safer and enhancing industrial applications. With 11,000 employees in 25 countries.

Irene Doerrer
Human Resources
+1 585 254 2000
Irene.Doerrer@roechling-advent.us

Röchling Medical Rochester
Holleder Technology Park, 999 Ridgeway Ave.
14615 Rochester, NY
United States

 
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