Job Title:R&D Engineer
Location: Marlborough, MA Onsite
Duration: 12 Months (W2 Only)
Employment Type: Contract (Only GC and USC)
Job Description:
Collaborate with design and project teams to define equipment requirements for new product development or legacy product management.
Develop manufacturing process flows, validation plans, and equipment qualification strategies (FAT, SAT, IQ, OQ, PQ).
Lead creation of protocols, test execution, and preparation of validation documents.
Conduct root cause analysis, design experiments (DOE), and implement process improvements.
Work on process FMEA, gage R&R, SPC, and statistical analysis for quality control.
Support manufacturing and market support teams in troubleshooting complex production issues.
Ensure compliance with FDA and ISO13485 regulations for U.S. and European markets.
Qualifications:
Bachelor’s degree (Master’s preferred) in Engineering or related field.
5+ years in manufacturing process development and validation (IQ/OQ/PQ).
Knowledge of machining, injection molding, thermoforming, ultrasonic welding, and similar processes.
Familiarity with FDA 21 CFR Part 820, ISO13485, and quality standards.
Strong problem-solving, organizational, and interpersonal skills.
Preferred Skills:
Experience with Class II/III medical devices.
Hands-on knowledge of process characterization and validation techniques.
