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Supplier Engineer 100% ONSITE - in Westlake Village, California Sponsorship is not available for this role. Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager : The Supplier Engineer is a key member of Caldera Medical's supplier management team, responsible for driving performance improvements, reducing supply risks, and ensuring components meet cost, quality, and manufacturability targets. This role partners closely with Sourcing, R&D, and Manufacturing Engineering to evaluate and develop suppliers, provide technical leadership on design-for-manufacturability, and support strategic sourcing decisions through cost analysis and process capability assessments. Acting as the primary technical liaison, the Supplier Engineer ensures suppliers have the capabilities, capacity, and controls needed to meet specifications, supports resolution of complex technical and quality issues, and leads cross-functional initiatives to strengthen the supply base and enable long-term business growth. Duties and Responsibilities :

• Collaborate with Sourcing to identify, qualify, and improve suppliers by assessing quality, service levels, cost, and manufacturing processes.
• Serve as the primary technical liaison between suppliers and internal teams for new product development, design changes, and issue resolution.
• Develop Should-Cost Models for major sub-commodities to support sourcing decisions.
• Lead purchase part approval processes. Contribute to risk analysis (PFMEA), validation plans, control plans, evaluate process capability (Cpk, Ppk), and support measurement capability (Gage R&R) studies.
• Evaluate suppliers' technical competencies, capabilities, and capacity to inform sourcing strategies.
• Partner with R&D and Manufacturing Engineering to review product requirements, validation objectives, and applicable standards.
• Provide and solicit DFM feedback; manage supplier communications on specifications and engineering changes.
• Investigate material quality issues, ensuring effective corrective actions are identified, implemented, and verified with suppliers.
• Assess and validate supplier change requests, ensuring proper testing, documentation, and implementation.
• Additional duties may be assigned in support of business needs. Required Knowledge, Skills and Abilities :
• Bachelor's degree in engineering or related discipline with 4+ years of relevant experience, or equivalent combination of education and experience.
• Preferred : knowledge of extrusion, injection molding, and metal forming.
• Experience with quality systems meeting FDA QSR, ISO 13485, MDD, GMP, and GDP requirements.
• Proficiency in SolidWorks
• Familiarity with operations techniques, benchmarking, and continuous improvement tools (Lean).
• Strong technical skills in risk management and remediation.
• Proven ability to create detailed project plans.
• Knowledge of Design Control procedures and requirements.
• Experience with test method validation and product / process changes / validation.
• Ability to work independently and collaboratively. Competitive Compensation, Comprehensive Benefits, and more!
• $90,000 - $110,000 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 holidaysincluding your birthday!
• Being surrounded by amazing people! (This role is being filled internally, and we are not engaging external agencies at this time.) 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.