Project Engineer

100% ONSITE - Westlake Village CA

(This role is not eligible for work visa sponsorship)

Message from the Hiring Manager:

The Project Engineer will lead projects and provide technical expertise to ensure the ongoing reliability, compliance, and cost-effectiveness of our existing medical device products. This role is crucial for supporting products throughout their lifecycle by resolving manufacturing issues, implementing design changes, and leading continuous improvement initiatives. The engineer will collaborate with cross-functional teams, including manufacturing, quality, supply chain, and regulatory affairs, to address challenges and maintain product quality.
Duties and Responsibilities:

Project Leadership: Lead small to intermediate-sized sustaining engineering projects, including product and process improvements, cost reduction initiatives, and component obsolescence management.

Manufacturing Support: Act as a primary R&D resource for manufacturing and production issues. Work closely with the manufacturing engineering team to troubleshoot and perform root cause analysis on product and process failures and implement effective corrective and preventive actions (CAPAs).

Design and Process Changes: Coordinate and complete the following as needed for all sustaining engineering objectives:

a. Project Schedule

b. Quality and Regulatory documents

c. Labeling and IFU changes

d. Design Requirements - Trace Matrix

e. Design Specifications - Trace Matrix

f. Real Time Aging retention, testing

g. V&V testing, documentation

h. Testing protocols and reports

i. Support Engineering Evaluation of returned product when needed.

j. Competitive product evaluation including standard testing

k. Support change Orders, technical review, implementation when needed

Required Knowledge, Skills and Abilities:

Education: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.

Experience: 4+years of experience in a regulated industry, with a strong emphasis on medical device product development or sustaining engineering. Experience with Class II or Class III medical devices is preferred. Experience in medical device component and material processing, design, and manufacturing. A comprehensive understanding of ISO, GMP and FDA regulations for the development.

Other Requirements:

1. Strong analytical and problem-solving skills and comprehensive understanding of design control processes, risk management, and validation of processes/designs.

2. Proven project management skills.

3. Experience with lean manufacturing and continuous improvement methodologies

4. Effective verbal, presentation and written communication skills.

5. Proficient in Microsoft Office, and MS project.

6. Working experience in Solidworks.

7. Working knowledge of medical device development, sterilization requirements and techniques, and medical device regulations.

8. Additional responsibilities may be assigned as needed to support business objectives.

Travel Required

• 10%

Competitive Compensation, Comprehensive Benefits, and more!

• 100k-$125k Annual Salary
• Medical and Dental Benefits – 75% paid for employee and family members
• Vision Coverage
• 401(k) with 4% matching contributions after 90 days of employment
• Basic Life and AD&D
• Unlimited Vacation Policy
• 6 Weeks Paid Maternity Leave
• 10 paid holidays
• Being surrounded by amazing people!

(This role is being filled directly by our in-house recruiting team. We are not working with outside agencies for this position.)

Our Culture- Where Career and Passion come together!

• A Culture of family and team… not a corporate goliath where you’re just another number.
• All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
• The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.
• Our goal is to treat 1 million women suffering from incontinence by 2027!

Who is Caldera Medical?

Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.