Senior Manufacturing Process Engineer
Manufacturing | Agoura Hills, CA | Full Time
Message from the Hiring Manager:
Senior Process Engineer will lead transformative change of manufacturing processes to achieve greater efficiency through fundamental engineering principles. Seeking a self-starter who can drive positive change in a dynamic, diverse work environment. Ideal candidate will demonstrate work history of leading complex projects; such as, process improvement and quality initiates; thus, creating practical solutions to technical challenges. Candidate must be comfortable thriving in a collaborative environment and comfortable with change.
Duties and Responsibilities:
- Develop new manufacturing processes, tools, equipment to enable low cost, high quality manufacturing.
- Effective communicator: Lead teams discuss and obtain consensus at all levels.
- Troubleshoot and implement corrections for challenges and issues encountered in manufacturing
- Design and qualify new processes, tooling & equipment from concept to production.
- Characterize and validate new methods (e.g. Gage R&R)
- Develop highly capable manufacturing processes for existing products.
- Lead manufacturing transfer of production from acquired entities.
- Create and maintain the documentation necessary to ensure the consistent manufacture of products.
- Assist in smooth transfer of new processes onto the production line.
- Apply fundamental engineering principles to create practical solutions to technical challenges and provide technical support across functions.
- Perform root cause analysis and develop corrective and preventative actions for quality systems and production issues.
- Manage and support CAPA and NCR documentation as needed.
- Develop a manufacturing plan for line extensions.
Required Knowledge, Skills and Abilities:
- Demonstrate history of driving manufacturing process improvement/efficiencies. Examples include designing more efficient tools, gauges and processes from concept to production implementation to yield measurable improvement in cost, quality and delivery.
- Bachelor’s Degree in Biomedical and/or Mechanical Engineering
- 5 + years of experience in regulated environment
- Experienced with tool design and validation
- Current Solidworks user.
- Green belt or equivalent experience.
- Previous medical device or equivalent experience preferred.
- Excellent rapport building and negotiation skills.
- Proven process improvement and problem-solving skills.
- Strong computer skills, including Microsoft Word, Microsoft Excel, Microsoft Project, Minitab, Solidworks, etc.
- Familiarity and expertise with statistics, ability to analyze data, interpret results and write technical reports.
- Working knowledge of GMP and ISO regulations.
- Comply with applicable FDA and international regulatory laws/standards.
- Must be able to work in a dynamic environment with little supervision or daily direction.
- Strong, team-oriented professional with good interpersonal skills and project management experience.
Who is Caldera Medical?
Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. 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’s leadership team lives the core values it believes. It’s great to see true leaders set the tone for their employees by teaching them how to be happy individuals.”
-Jose Charvet, Sr. Mechanical Engineer
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 2025!
Competitive Compensation, Comprehensive Benefits, and more!
- 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- including your birthday!
- Being surrounded by amazing people!
Hear it from our very own! Learn more about Caldera on Glassdoor
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.