Mechanical Engineering Senior

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Mechanical Engineer

We are looking for a Senior Mechanical Engineer to provide technical leadership for complex Class II and Class III medical devices. The role will support product design, sustaining engineering, verification, reliability, investigations, and manufacturing activities.

Lead sustaining engineering activities for medical devices.

Lead technical investigations, complaints, CAPAs, and nonconformances.

Perform root cause analysis and failure investigations.

Develop test methods, protocols, fixtures, and equipment.

Evaluate product performance and reliability.

Support risk management and FMEA activities.

Review engineering drawings, specifications, tolerances, and GD&T.

Perform tolerance analysis and engineering stack-ups.

Mentor engineers and provide technical coaching.

Evaluate machining, injection molding, extrusion, welding, bonding, and assembly processes.

Analyze manufacturing, complaint, post-market, and reliability data.

Support reliability testing, accelerated life testing, fatigue analysis, DOE, SPC, and Six Sigma activities.

Work with R&D, Quality, Regulatory, Manufacturing, Operations, Suppliers, and Clinical teams.

Support regulatory submissions, audits, inspections, and regulatory inquiries.

Support external manufacturing partners and global suppliers.

Contribute to continuous improvement, product quality, and operational excellence.

Bachelor s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related field.

15+ years of engineering experience in Class II and/or Class III medical devices.

Experience in product development, sustaining engineering, verification and validation, manufacturing support, and risk management.

Strong experience with mechanical design, GD&T, tolerance analysis, materials, and manufacturing processes.

Experience leading technical investigations and root cause analysis.

Experience with FMEA and medical device risk management.

Experience with CAD systems and engineering drawings.

Experience with medical device manufacturing processes.

Experience with VADs, extracorporeal blood pumps, oxygenators, cardiovascular implants, or other Class III medical devices is highly relevant.

Experience with complaint investigations, CAPA, post-market surveillance, and reliability activities.

Knowledge of ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.

Experience with DOE, SPC, Six Sigma, reliability engineering, or statistical analysis.

Experience working with suppliers and external manufacturing partners.

Master s degree in Mechanical Engineering, Biomedical Engineering, or a related field is beneficial.

Ability to travel approximately 10%, including domestic and occasional international travel.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.

#