Plastic Injection Molding Process Engineer Rochling Medical - 2.3 Rochester, NY Job Details Full-time $87,500 - $105,000 a year 21 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Tuition reimbursement Paid time off Vision insurance 401(k) matching Life insurance Retirement plan Qualifications Customer communication Interpersonal skills Bachelor of Science Bachelor's degree Training & development FDA regulations Full Job Description Roechling Medical Rochester offers customers a wide range of high-quality, customized components and assemblies, right through to end-to-end OEM products. The product portfolio also includes standard plastic products, with special expertise in the fields of diagnostics, fluid management, pharma, surgery and interventional, and much more. These areas of competence are complemented by an enhanced range of services for development and regulatory affairs, right through to approval of end-to-end medical products. Job 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

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. Roechling Medical Rochester (RMR) is an Equal Opportunity Employer. RMR does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Job Type:

Full-time Pay:

$87,500.00 - $105,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Retirement plan Tuition reimbursement Vision insurance

Work Location:

In person