Senior Product Development Engineer - VahatiCor

Title: Senior Product Development Engineer - VahatiCor

Status: Full-time, Exempt

Reports to: Sr. Director of R&D

About The Role

VahatiCor is looking for a hands-on Senior Product Development Engineer to join our fast-paced startup team. We are seeking an individual with a proven track record of delivering products to market and strong experience in Delivery system development.

This engineer will work in close collaboration with Process development, Quality, and Manufacturing to establish robust designs and processes that ensure repeatable quality.

Key Responsibilities

• Develop best in class cardiovascular catheter systems to address clinically unmet needs
• Drive program success by providing technical leadership and project oversight for external development partners, ensuring alignment on design inputs, development activities, and validation strategies
• Partner with external suppliers to proactively identify and resolve supplier processing issues, ensuring all components and subassemblies meet established performance specifications
• Define critical product specifications based on clinical needs, complete with formal justification and the development of associated test methods
• Develop and qualify test procedures to assess critical quality attributes and product specifications
• Design and implement fixtures and methodologies for product testing
• Author and execute comprehensive engineering protocols and reports to support all phases of Design Verification and Validation
• Author and maintain process documentation (MPIs, SOPs, work instructions, test methods, protocols, and validation reports)
• Partner with Regulatory and Quality to ensure all processes meet FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements
• Partner with Manufacturing and Process development to ensure proper transfer of catheter manufacturing processes from external contract manufacturers to internal operations
• Plan and execute process characterization, DOE, and capability studies to ensure consistency and scalability
• Perform/support root cause analysis and corrective actions (CAPA) to address product issues and supplier corrective actions (SCARs) to address issues at the supplier
• Support equipment selection and help define qualification (IQ/OQ/PQ), and preventive maintenance programs
• Collaborate with Quality and Regulatory to ensure DHF readiness for audits and inspections
• Identify continuous improvement initiatives for product performance, throughput, yield, cost, and manufacturability
  
  

Qualifications

• Bachelor's degree in Mechanical, Biomedical, or related Engineering discipline
• 5 years of hands-on process development experience in the regulated medical device industry (catheter or interventional device strongly preferred)
• Demonstrated success in process transfer, scale-up, and validation
• Experience with catheter assembly, bonding, molding, extrusion, and testing methods
• Strong knowledge of FDA QSR, ISO 13485, and risk management standards
• Proficiency in equipment qualification (IQ/OQ/PQ), DOE, and statistical analysis tools
• Strong documentation and communication skills; able to thrive in a dynamic startup environment
• Hands-on, proactive problem-solver with startup mentality
  
  

Eligibility

Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas or permanent residency (PERM) applications.

Location and Compensation

This role is based in Santa Clara, CA, and is open to candidates living within a reasonable commuting distance of our office. At this time, we are not considering applicants who would need to relocate, either within or outside of California. There is no relocation package available.

VahatiCor is committed to fair and equitable pay practices and may consider additional compensation elements such as bonuses, equity, and benefits as part of the total rewards package.

Salary ranges are based on San Francisco Bay Area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as the geographic location of the individual hired.

The anticipated salary range of this position is $132,000 - $178,000 based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills.

Please note that the top of the salary range is reserved for candidates who demonstrate exceptional qualifications and experience directly aligned with the requirements of the role. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations.

Equal Opportunity Statement

VahatiCor is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected status.

Third-Party Recruiter Notice

We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of VahatiCor, and no fees will be paid if the candidate is hired. If your agency or firm would like to officially submit candidates for any of our posted roles, please email careers@t45labs.com.