Verification and Validation RD Engineer

1 week ago

Marlborough, United States Compunnel Full time
Job Summary

The Verification and Validation RD Engineer will be responsible for ensuring the successful development and qualification of manufacturing processes, equipment, and products. This role involves collaborating with cross-functional teams to define equipment specifications, develop validation protocols, and support both new product introductions (NPI) and legacy product improvements. The engineer will apply analytical problem-solving methods and lead qualification activities to ensure that processes meet regulatory and quality standards.

Key Responsibilities
  • Collaborate with Product Design & Multi-Functional Teams: Work closely with the product design team, suppliers, and other stakeholders to establish equipment requirements and align them with reliability and quality specifications.
  • Develop and Implement Validation Plans: Create the Master Validation Plan, Qualification Strategy, and Manufacturing Process Flow for new products or improvements to legacy products.
  • Problem-Solving & Data Analysis: Utilize analytical methods, including Root Cause Analysis and Design of Experiments (DOE), to resolve complex manufacturing and product-related issues.
  • Lead Qualification Documentation: Own and lead the preparation, execution, and documentation of qualification protocols and test reports, including Factory Acceptance Tests (FAT), Supplier Acceptance Tests (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process FMEA, Gage R&R, and Statistical Process Control (SPC).
  • Develop Standard Methodologies: Publish and enforce standard methodologies for process development, and mentor team members on best practices and lessons learned.
  • Support Manufacturing & Market Teams: Assist the Manufacturing Engineering and Market Support teams with troubleshooting and resolving complex issues related to legacy products, such as production problems and customer complaints.
  • Cross-Functional Team Collaboration: Work in a multidisciplinary Research and Development team, liaising with Production, Supply Chain, Sourcing, Quality, and external suppliers to ensure smooth project execution.
Required Qualifications
  • Educational Background: Bachelor’s degree required; Master’s degree (or equivalent) in related scientific or engineering fields such as mechanics, micro-mechanics, or engineering is preferred.
Experience:
  • 5+ years of experience in designing, developing, transferring, and maintaining manufacturing technologies and processes, particularly within regulated industries (e.g., medical devices, class II and/or class III).
  • 5+ years of experience in performing qualification and validation of manufacturing processes (IQ, DOE, OQ, PQ, Process FMEA).
  • Regulatory Knowledge: In-depth understanding of relevant regulations such as ISO 13485 and FDA 21 CFR Part 820, particularly for product submission to the US and European markets.
  • Technical Skills: Experience with various manufacturing processes, including machining, injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding, automated assembly, labeling, and packaging.
Preferred Qualifications
  • Problem-Solving Abilities: Self-starter with hands-on experience and a creative approach to problem-solving, capable of addressing conflicting requirements and technical challenges.
  • Interpersonal Skills: Strong organizational and communication skills, with the ability to collaborate effectively in cross-functional teams and mentor colleagues.
Certifications
  • Certifications: Any relevant certifications in process validation, quality management systems (e.g., Six Sigma, Lean, etc.), or regulatory affairs are a plus but not required.


Note - 100 Results Way, Marlborough MA 01752

Education: Bachelors Degree

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