Principal Engineer

Title: Principal Engineer

Pay: $80.00–$86.00/hour

Hours: Monday–Friday, 9:00 AM–5:00 PM PST

Location: Santa Clara, CA 95054 – Onsite

Duration: 6 month contract with potential for extension

Haemonetics is seeking an experienced Principal Engineer to support the design and development of innovative medical devices within the Vascular Closure Group. This is a senior‑level, hands‑on engineering position requiring strong technical expertise, project leadership, and the ability to independently drive projects from development through commercialization.

The Principal Engineer will serve as a lead design engineer on Disposable R&D projects, balancing hands‑on laboratory work with project management, testing, documentation, and cross‑functional collaboration.

• Lead R&D activities related to product sustaining, life‑cycle management, CAPAs, SCNs, and design‑related initiatives for disposable medical devices.
• Manage project timelines, deliverables, priorities, and deadlines while coordinating closely with project management and cross‑functional teams.
• Perform extensive hands‑on laboratory work, including device testing, troubleshooting, prototype development, and lab equipment maintenance.
• Design and create prototypes, fixtures, and samples for marketing, manufacturing, and product development activities.
• Lead projects of varying size and complexity while managing scope, timelines, budgets, risks, and communication.
• Partner with Manufacturing, Regulatory, Quality, and other teams to move products from concept through commercialization.
• Develop and execute test protocols and reports for medical device design and verification activities.
• Develop clinically relevant benchtop test models and methods to evaluate device performance.
• Support preclinical testing as needed to investigate product performance.
• Analyze experimental data using statistical techniques, including DOE and ANOVA.
• Manage Design Control activities and Design History File (DHF) deliverables in accordance with internal SOPs, FDA requirements, and international regulations.
• Support IQ/OQ activities for laboratory equipment, including preventive maintenance and calibration.
• Prepare technical reports, project updates, and presentations for senior leadership.
• Attend project meetings, one‑on‑ones, and cross‑functional meetings as required.
• Independently identify critical paths, mitigate project risks, and ensure projects continue progressing according to established timelines.

• Minimum 7 years of medical device industry experience
• Advanced CAD experience, preferably Solid Works
• Working knowledge of Medical Device Design Control
• Demonstrated ability to work independently and drive projects with limited oversight.
• Hands‑on experience with medical device testing, troubleshooting, and prototype development.
• Experience managing Design History File elements and quality system requirements.
• Experience with IQ/OQ of laboratory equipment, preventive maintenance, and calibration.
• Experience with product concept development, customer needs, design requirements, and validation.
• Knowledge of statistical study design and analysis, including DOE and ANOVA.
• Understanding of GMP, QMS, FDA, and international medical device regulatory requirements.
• Strong mechanical aptitude and fixture‑design capabilities.
• Strong project and time‑management skills with the ability to manage scope, deadlines, risks, and competing priorities.
• Strong written, verbal, and presentation skills.
• Ability to work effectively with Manufacturing, Quality, Regulatory, and other cross‑functional stakeholders.

• Cardiovascular catheter delivery system or similar device experience.
• Experience with high‑volume manufacturing environments.
• Experience with IDE, PMA, and Class III medical devices.
• Familiarity with AGILE.

Bachelor’s degree in a technical discipline such as Mechanical Engineering, Manufacturing Engineering, Bioengineering, Industrial Engineering, or a related field preferred.

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified…