MDR - Product Engineer II

Job Duties

We are seeking a Manufacturing Engineer II to support medical device manufacturing and labeling activities in a regulated environment. This position will have a strong focus on labeling changes and implementation, packaging, and EU MDR requirements.

Key Responsibilities

• Manage and implement product labeling changes, ensuring accurate execution and regulatory compliance.

• Support EU MDR (EUMDR) labeling and product requirements.

• Provide manufacturing engineering support for medical device and combination product production.

• Support packaging processes and associated changes.

• Investigate and disposition nonconforming product and support corrective actions.

• Identify and implement process improvements to improve quality, efficiency, and yield while reducing scrap.

• Develop, maintain, and improve manufacturing processes and procedures.

• Troubleshoot manufacturing, testing, equipment, specification, and production issues.

• Utilize statistical process control and problem-solving methodologies to drive improvements.

• Collaborate with cross-functional teams on engineering changes and manufacturing initiatives.

• Ensure manufacturing processes and documentation comply with applicable regulatory and quality requirements.

Minimum Education Required

• Bachelor’s degree in Engineering, preferably Mechanical, Biomedical, Chemical, Industrial, or a related discipline.

Minimum Experience Required

Required Qualifications

• 2+ years of relevant engineering experience, or a Master’s degree with 0+ years of experience.

• Strong attention to detail.

• Experience working in a medical device or regulated manufacturing environment.

• Experience with packaging and/or product labeling.

• Strong problem-solving, communication, and organizational skills.

Preferred Qualifications

• 2–4 years of manufacturing/operations engineering experience.

• Experience supporting labeling changes and implementation.

• Knowledge of EU MDR requirements.

• Experience with medical device packaging.

• Experience with structured problem-solving methodologies such as DMAIC.

• Experience with statistical analysis software such as JMP or Minitab.

• Ability to work independently while collaborating effectively with cross-functional teams.

Shift

First (Day)

Number of Openings

1

Public Transportation Accessible

Yes

Veterans Encouraged to Apply

Yes

Physical Required

No

Drug Test Required

Yes

Compensation

$37.00 - $45.00 / Hourly

Postal Code

55441

Job Type

Contract (W2)

Place of Work

On-site

Requisition ID

6793

Job Benefits

Health Insurance, Life Insurance, 401k retirement plan, paid sick time

Application Instructions

If interested and qualified, please submit your resume to [email protected] or visit our website to apply: http://dr-group.com/find-engineering-technical-jobs/