About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Engineering.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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Role Overview

The Confidential Client is seeking an entry-level R&D Engineer to support development, validation, and continuous improvement of manufacturing processes for medical devices. This contract role offers hands-on experience with process validation (IQ/OQ/PQ/PPQ), equipment qualification, technical documentation, and cross-functional collaboration in a regulated manufacturing environment.

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Responsibilities

• Author, execute, and support process validation activities including Test Method Validation (TMV), Inspection Method Validation (IMV), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Product Performance Qualification (PPQ).
• Lead and support process development projects from concept through full implementation in manufacturing.
• Assist with equipment specification, acquisition, qualification, and deployment.
• Design and execute experiments to evaluate processes, equipment, and materials.
• Analyze validation and test data to identify trends, variability, and improvement opportunities.
• Present findings and recommendations to engineering and project teams.
• Evaluate existing manufacturing processes and equipment for robustness and efficiency.
• Develop and maintain technical documentation: SOPs, manufacturing specs, validation protocols/reports, risk assessments, safety instructions, and work instructions.
• Collaborate with engineers, technicians, and cross-functional teams to implement process and equipment improvements.
• Support continuous improvement initiatives focused on quality, compliance, efficiency, and safety.
• Provide training and technical expertise related to tooling, process development, and validation activities.
• Coordinate with internal stakeholders and external partners to meet technical requirements and timelines.

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Essential Skills & Experience

• Bachelor’s degree in Engineering, Manufacturing, Life Sciences, or related technical discipline (Mechanical, Biomedical, Chemical, etc.).
• 1–3 years of engineering experience preferred; entry-level candidates with relevant internships, co-ops, or academic project experience in a regulated environment are encouraged to apply.
• Familiarity with medical device processes and quality standards; understanding of validation and process development activities.
• Technical writing skills with the ability to produce clear, compliant SOPs, validation reports, and work instructions.
• Ability to design experiments, collect and analyze data, and draw actionable conclusions.
• Strong collaboration and communication skills; attention to detail and a structured approach to documentation and validation.

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Additional Skills & Qualifications

• Exposure to TMV, IMV, IQ, OQ, PQ, and PPQ is a plus.
• Experience supporting process development from concept through implementation.
• Familiarity with risk assessments, safety instructions, and continuous improvement methodologies (e.g., Lean, Six Sigma basics).
• Comfortable presenting technical findings to engineering and project teams.
• Interest in growing a career in medical device R&D and manufacturing.

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Work Environment & Schedule

This is a fully onsite position in Hopkins, MN. Typical schedule is Monday–Friday, 8 hours/day with flexible start/end times within a general 6:00 a.m. to 5:00 p.m. window. The assignment is an initial 6-month contract with potential to extend or convert to direct hire based on performance and business needs. You will work in a professional medical device manufacturing and engineering setting, following established safety and quality procedures.

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Job Type & Location

• Contract (initial 6 months) — onsite in Hopkins, MN (Hopkins, MN).

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Compensation & Benefits

• Pay range: $35.00 - $36.00 per hour. Actual compensation within this range will depend on qualifications, experience, and other job-related factors.
• If eligible, benefits for this temporary role may include: medical, dental & vision; critical illness, accident, and hospital plans; 401(k) with pre-tax and Roth options; voluntary life & AD&D; short- and long-term disability; HSA; transportation benefits; Employee Assistance Program; and paid time off subject to eligibility and plan terms.

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Compliance, Accommodations & Notes

• Confidential Client is an equal opportunity employer and considers applicants without regard to legally protected characteristics. Careertakes supports a fair hiring process on behalf of our client.
• If you need a reasonable accommodation during the application or interview process due to a disability, please notify Careertakes so we can coordinate with the hiring team.
• This role may use AI tools to assist with application review or resume screening; AI assists but does not replace human decision-making.

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.