Senior Manufacturing / Process Validation Engineer Contract Medical Device Manufacturing | Onsite | 4 6 Week Initial Assessment Position Overview
We are seeking a senior-level Manufacturing / Process Validation Engineer to support a medical device manufacturing project involving an existing customer product line. The project is focused on evaluating current manufacturing processes, reviewing technical documentation, and identifying potential gaps before moving forward with additional production and validation activities.
The customer product line is already established, but production is being paused to allow for a comprehensive technical assessment. The engagement will approach the existing manufacturing process similarly to a new product transfer, ensuring that design requirements have been properly translated into manufacturing processes, risk assessments, and validation documentation.
The ideal consultant will have a strong background in medical device product design, manufacturing engineering, and process validation, with hands-on experience developing and reviewing technical documentation. This is a tactical, execution-focused engagement requiring someone who can independently evaluate existing documentation, identify deficiencies, and provide actionable recommendations.
The initial scope is strictly assessment and gap identification. Remediation, redesign, and execution of validation activities are not part of this phase. Key Responsibilities- Conduct a comprehensive assessment of an existing medical device manufacturing process, approaching the review with the rigor of a new product transfer.
- Review existing design documentation, engineering drawings, specifications, Design FMEAs (DFMEAs), Process FMEAs (PFMEAs), and related technical records.
- Evaluate how product design requirements, specifications, and identified risks have been translated into manufacturing processes and process controls.
- Assess alignment between design documentation, manufacturing instructions, process risk assessments, and existing process validation documentation.
- Identify gaps in manufacturing readiness, process validation, risk management, and supporting technical documentation.
- Evaluate existing process controls and their effectiveness in addressing product quality requirements and manufacturing risks.
- Review available IQ/OQ/PQ documentation, validation protocols, and supporting evidence, as applicable.
- Identify potential contributors to manufacturing scrap, process variability, and inefficiencies through documentation and process review.
- Work directly with manufacturing, quality, engineering, and project management stakeholders to understand current processes and clarify technical requirements.
- Develop a structured gap assessment outlining findings, associated risks, and recommended corrective actions for a potential subsequent project phase.
- Communicate findings and recommendations to internal stakeholders and support planning for future remediation or process validation activities.
Required Qualifications- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related technical discipline.
- 8+ years of experience in medical device product development, manufacturing engineering, process engineering, or process validation.
- Strong understanding of medical device product design and the translation of design specifications into manufacturing requirements.
- Demonstrated hands-on experience authoring, developing, and reviewing technical engineering documentation, including engineering drawings, DFMEAs, PFMEAs, and validation documentation.
- Experience supporting manufacturing process transfers, new product introduction (NPI), or manufacturing readiness assessments.
- Working knowledge of process validation methodologies, including IQ, OQ, and PQ.
- Strong understanding of manufacturing risk management, process controls, and identification of process-related quality gaps.
- Experience working within ISO 13485-regulated manufacturing environments.
- Ability to independently conduct technical assessments and clearly communicate findings to engineering, quality, and manufacturing leadership.
- Strong analytical and documentation skills with a practical, hands-on engineering approach.
Preferred Qualifications- Previous experience supporting medical device contract manufacturers or OEM product transfers.
- Experience assessing established manufacturing processes before transfer, relaunch, or additional validation.
- Familiarity with ISO 14971, design controls, and risk-based process validation.
- Experience investigating manufacturing scrap, process variation, or production yield issues.
- Prior consulting or contract engineering experience delivering technical gap assessments.
Engagement Details- Engagement Type: Contract / Consulting
- Initial Duration: Approximately 4 6 weeks, with up to 2 months anticipated for the overall assessment effort
- Location: Onsite; local candidates only
- Start Date: As soon as the updated customer purchase order is approved
- Project Focus: Manufacturing process assessment, technical documentation review, and gap identification
- Future Phases: Potential process remediation, validation execution, and production readiness support, depending on assessment findings and customer authorization (Don't worry about this for now)
Expected Deliverables- Technical Documentation Assessment: Review of applicable design records, engineering drawings, FMEAs, and existing manufacturing and validation documentation.
- Design-to-Process Traceability Review: Identification of gaps between product design requirements, manufacturing processes, and documented process controls.
- Manufacturing & Validation Gap Analysis: Assessment of current manufacturing processes, validation readiness, and potential sources of scrap or process variability.
- Prioritized Gap Assessment Report: Documented findings, risk prioritization, and recommended next steps for a potential remediation or validation phase.
Ideal Candidate Profile
We are looking for a technically strong, senior-level engineer who has personally developed the types of documents they will be reviewing. This individual should be equally comfortable interpreting product design requirements, assessing manufacturing risks, and evaluating process validation readiness.
The right consultant is not someone who exclusively manages projects or provides high-level quality oversight. We need a hands-on technical contributor who can get into the engineering details, recognize where requirements or process controls may be insufficient, and clearly document what needs to be addressed before the project moves into its next phase.