Principal Engineer

Creative Solutions Services, LLC; Santa Clara (CA); On-site; USD 229,233,000 - 246,425,000; Full time

Benefits offered by this job

Health insurance

Health savings account

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Retirement plan

Job summary

Haemonetics is seeking an experienced Principal Engineer to design and develop innovative medical devices in the Vascular Closure Group. This senior, hands‑on role balances development work with project leadership and cross‑functional collaboration to drive projects from concept through commercialization.

The candidate will lead R&D on disposable devices, execute test protocols, manage DHF deliverables, and partner with Manufacturing, Regulatory, and Quality teams.

Qualifications

• 7+ years of medical device industry experience.
• Advanced CAD experience, preferably SolidWorks.
• Working knowledge of Medical Device Design Control.
• Ability to work independently with minimal supervision.
• Hands-on experience with medical device testing, troubleshooting, and prototype development.
• Experience managing Design History File elements and quality system requirements.
• IQ/OQ of laboratory equipment, preventive maintenance, and calibration.
• Experience with product concept development, customer needs, design requirements, and validation.
• Knowledge of GMP, QMS, FDA, and international medical device regulatory requirements.
• Strong project and time-management skills with cross-functional collaboration.

Responsibilities

• Lead R&D activities for disposable medical devices including lifecycle management.
• Manage project timelines, deliverables, priorities, and deadlines with cross-functional teams.
• Hands-on lab work: device testing, troubleshooting, and prototype development.
• Design prototypes, fixtures, and samples for marketing, manufacturing, and product development.
• Lead projects, manage scope, budgets, risks, and communication.
• Collaborate with Manufacturing, Regulatory, Quality, and other teams to move products from concept to commercialization.
• Develop and execute test protocols and reports for medical device design and verification.
• Develop benchtop models and methods to evaluate device performance.
• Support preclinical testing as needed to investigate performance.
• Analyze data using DOE and ANOVA.
• Maintain Design History File (DHF) per SOPs and regulatory requirements.
• Assist IQ/OQ activities for lab equipment and calibration.
• Prepare technical reports and leadership presentations.
• Attend meetings and manage critical paths.

Skills

7+ years medical device experience

Independent work

Project leadership

Hands-on testing

DOE/ANOVA knowledge

Regulatory awareness

GMP/QMS experience

Design controls

Fixture design

Strong communication

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

SolidWorks

Job description

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

Overview

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.

Job Description

• 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.

Required Skills

• Minimum 7 years of medical device industry experience
• Advanced CAD experience, preferably SolidWorks
• 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.

Preferred Skills

• 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.

Education Requirements

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

Benefits (employee contribution)

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

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment‑qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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