Embolx, Inc Hiring for Medical Device Engineer Job at Sunnyvale, CA Full Time

Embolx, Inc. is an emerging commercial-stage medical device company located in Silicon Valley that is marketing a unique transarterial catheter for drug delivery and super-selective cancer therapy. The Embolx delivery system directs blood flow and pressure adjacent to cancerous tumors or in the prostate, thereby improving the quantity and distribution of embolic agents. Our technology improves survival, reduces variability, and results in fewer complications. Sniper® is an FDA and CE/ISO cleared balloon occlusion microcatheter that supports a medical technique that is minimally invasive, reduces medical costs and is expected to be a breakthrough in drug delivery and cancer therapy.

Embolx has an entrepreneurial culture where we value a team environment, innovation, and a laser-sharp focus on the needs of our customers. As an emerging company, we expect our team members to make a commitment to achieve company goals in a meaningful timeframe. This commitment includes the willingness to do whatever it takes to get the job done and work beyond regular business hours. This is an opportunity to work with a team and build a company through the initial stages of commercialization and be part of an effort that is truly unique.

General Position Summary

If you have a successful track record in medical device development and manufacturing and would like to participate in a fast-paced entrepreneurial environment where your effort makes a difference, this position is perfect for you. The Medical Device Engineer is responsible for new product development, product improvements and will support QC. This includes reviewing, analyzing and managing feedback and complaints, corrective/preventive actions, production lot releases, non-conforming material, assisting engineering with tests, supporting new product introductions and supporting the sustaining engineering activities while supporting Quality, Regulatory and R&D efforts. This position reports to both the Director of R&D and the Quality Manager and will support and interact directly with development team and contract manufacturing groups. Experience within a regulated medical device environment and within ISO 13485, FDA GMP, 14971, and GMP standards are required.

Specific Duties and Responsibilities

· Develop product improvements and maintain high performance standards for existing products.

· Conduct research and development on new products.

· Support product manufacturing.

· Assist with engineering testing or verification testing as needed.

· Review and manage feedback and customer complaints. Analyze the same for trends, issues, product improvement and management review.

· Coordinate with QC and manage non-conforming material reports, manufacturing change requests and associated materials.

· Investigate or assist with corrective and preventive actions.

· Assist in regulatory audits.

· Produce metrics and provide to management for review.

· Audit suppliers.

· Prepare and conduct experiments to support manufacturing, engineering efforts and run development validations.

· Maintain a lab notebook of all engineering and experiment activities

· Assist with manufacturing activities during design transfer, FMEA testing, and production validation oversight.

· Support investigations on product build, production processes and testing for flaws and identify improvements to improve product and yields. Support engineering and manufacturing in determining and eliminating root causes of yields and complaint issues and work to diminish occurrences. Ensure customer complaints are resolved to ensure customers are delighted with the product.

· Support development and operations in making suggestions for the development of tooling / fixtures for building the product to ensure consistent manufacturing and product outcomes.

· Operate in a regulated medical device environment with competence in FDA, ISO (13485, 14971) and GMP quality system compliance and maintenance.

Education and Experience

· Bachelor’s Degree in mechanical engineering, biomedical engineering or equivalent preferred

· A minimum of a 5 years’ experience in medical device R&D and well versed in FDA/ISO standards as related to the medical device industry and manufacturing Quality requirements.

Skills and Abilities

• Proficient in SolidWorks and the ability to thoroughly test and troubleshoot is a must.
• Thoroughly knowledgeable about FDA, ISO, GMP and other quality protocols.
• Writing and updating quality documentation.
• Ability to multi-task, including providing support for other projects as needed.
• Outstanding communication, critical thinking and analytical problem-solving skills.
• Excellent organizational and time-management skills, with a strong sense of responsibility and adherence to deadlines.
• Ability to quickly adapt to change and daily work focuses.
• Team player with good collaborative skills.
• Proficient with MS Office.

Apply today! If you would like to participate in a fast-paced entrepreneurial environment, we would like to talk with you. Please submit your resume and cover letter.

We offer a competitive compensation package, including unlimited vacation.

Embolx is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer. Employment decisions are considered regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Work Remotely

• No

Job Type: Full-time

Pay: $100,000.00 – $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

COVID-19 considerations:
All employees at Embolx are vaccinated or are tested weekly.

Experience:

• Medical Device R&D: 5 years (Preferred)

Work Location: One location