Job description

**$1500 Sign-On Bonus**

Richard Wolf Medical Instruments Corporation is currently seeking a Production Transfer Engineer in Vernon Hills, IL. The Production Transfer Engineer is responsible for providing engineering, technical, and/or documentation support for production transfer in accordance with the requirements of the organization.

REQUIREMENTS AND RESPONSIBILITIES:

• Work in cooperation with, and takes cues or direction from, the Production Transfer Manager on all production transfer projects.
• Assists with production transfer projects on testing and inspection, exploratory study, validation, qualification, calibration, fixtures, and documentation.
• Assists with or is responsible for the corresponding implementation and verification of the project(s).
• Gather the necessary information and documentation from RW GmbH, RWMIC or other transfer location.
• Works and collaborates interdepartmentally within the Richard Wolf organization, especially with the Quality Group and the various Production Managers within the Manufacturing Department.
• Assists with, or works with, outside service vendors or 3rdparties that may be needed to fulfill the processing of any parts involved in the production transfer.
• Responsible for the supporting the efficient transfer of production to RWMIC, taking into account the following points:Ensure all necessary resources are trained, available, and documented.

Transfer and establish all necessary or potentially applicable DMR, DHR, DHF, or other documentation that may be required.
Create and/or update applicable procedures, work instructions, forms, and any other documentation as needed.
As directed, support the authoring and execution of process validations.
Preparation of evaluations concerning the local procurement of materials.
For local procurement of materials, make sure that the relevant suppliers are qualified and are subject to vendor management.
Ensure risk assessment activities are executed and maintained according to regulatory standards.

ADDITIONAL RESPONSIBILITIES:

• Comply with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820, cGMP guidelines, GDP, ISO 13485, ISO 14971 and other regulatory requirements.
• Awareness of and complies with the RWMIC Quality Manual and any applicable laws and regulations as they apply to this job type/position.
• Complete all planned Production, Quality & Compliance training within the defined deadlines.
• Other duties as assigned by Corporate Director of Manufacturing.

QUALIFICATIONS:
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)

• B.S. Degree in applicable technical discipline, such as mechanical, Industrial, bio-medical, or chemical engineering.
• Relevant certifications demonstrating applied understanding of medical device quality system requirements, such as AAMI Quality System or sterilization certificates, Certified ASQ or ISO Lead Auditor and Regulatory Affairs Professional Society (RAPS) preferred.
• Applied understanding of statistical methodologies and tools, such as Six Sigma & Mini Tab.
• OSHA experience preferred.
• Manufacturing environment experience preferred.
• Excellent communication skills.
• Intermediate to Advanced PC knowledge and working experience with spreadsheets, presentations and report writing tools.
• Experience with, and understanding of, cross-cultural differences and the ability to work within this environment is crucial for successful employment.
• The following physical demands are required:Stand/Sit/Walk 8 hours per day.
• RWMIC offers annual Immunizations for Hep B and Flu Shots to all RWMIC employees. RWMIC employees have the responsibility to themselves and the company to consider receiving these immunizations.
• All RWMIC Employees have the responsibility to themselves and the company to work safely.

We offer competitive wages and a comprehensive benefits package, which includes:

• 401 (k) Retirement Savings Plan and Trust w/Matching Program
• Medical Insurance, Dental and Vision Insurance
• Company Paid Life & Disability Insurance
• Paid Time Off
• Paid Parental Leave
• Flexible Schedules
• Tuition Reimbursement
• Wellness Program
• Flexible Spending Accounts

At Richard Wolf, we believe in creating a workplace where everyone has the opportunity to thrive. We are committed to providing equal employment opportunities to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, status as a protected veteran, or any other legally protected status. We celebrate diversity and welcome all qualified candidates to apply for open positions.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Experience level:

• Under 1 year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Application Question(s):

• Desired Salary:

Work Location: In person

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