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Role: Quality Engineer – Medical Device

Location:  Delaware

Largescale Medical Device client facing a remediation project here on site in Delaware.

What is the project the contractor will be working on?

•              We are seeking experienced Quality and/or Manufacturing Engineers to support a large-scale production documentation and remediation initiative at our client’s Newark, Delaware manufacturing site. These professionals will play a critical role in strengthening risk management practices, supporting transfer to manufacturing activities, and driving process validation and equipment qualification efforts.

o             This engagement will begin with comprehensive documentation gap assessments across multiple production lines, followed by remediation and implementation activities to ensure manufacturing readiness and compliance.

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Quality Engineer (Remediation)

Documentation Gap Analysis

•              Perform detailed reviews of production line documentation, including:

o             Process documentation

o             Work instructions

o             Training records

o             Validation documentation

o             Specifications and technical drawings

•              Identify documentation gaps, inconsistencies, and compliance risks.

•              Partner cross-functionally with manufacturing, quality, and engineering teams to prioritize findings.

Remediation & Implementation

•              Develop and execute remediation plans following gap assessments.

•              Update and create SOPs, work instructions, and validation documentation as needed.

•              Support transfer-to-manufacturing activities through structured risk mitigation.

•              Ensure documentation aligns with regulatory and internal quality standards.

Risk Management & FMEA

•              Lead and/or support:

o             Process FMEAs

o             Risk assessments tied to manufacturing transfer

o             Risk mitigation planning and documentation

•              Apply strong risk management principles to process validation and equipment qualification activities.

Process Validation & Equipment Qualification

•              Support process validation activities including:

o             IQ/OQ/PQ execution

o             Equipment qualification documentation

o             Validation protocol review and approval

•              Ensure alignment between validation activities and risk management outputs.

Technical Review & Support

•              Review engineering drawings and specifications to confirm accuracy and alignment with production processes.

o             Ability to read and interpret drawings is required (drafting not required).

•              Support sampling plan assessments:

o             Evaluate sampling plans and statistical justifications

o             Determine appropriate sample sizes and rationale

•              Participate in production line startup and manufacturing support as needed.

Skills:

Required:

•              3–6+ years of experience in Quality Engineering (QE) and/or Manufacturing Engineering within Medical Devices

•              Strong experience leading or supporting:

o             Process FMEAs

o             Risk management initiatives

o             Process validation activities

•              Experience reviewing and remediating manufacturing documentation.

•              Working knowledge of equipment qualification (IQ/OQ/PQ).

•              Ability to interpret engineering drawings and technical specifications.

Desired:

•              Experience with instrumentation and electronics (strong plus for the Delaware site).

•              Experience assessing sampling plans and statistical justifications (preferred but not required).

•            

•              Exposure to:

o             Plastics manufacturing

o             Chemistry-based processes or test strip formulation

o             Experience supporting multi-site environments.

Best Regards,

Satya Satish J | Technical Recruiter | IT Minds LLC |