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 oversight for external development partners ensuring alignment on design inputs system architecture development activities and verification strategies.

Partner with external suppliers to proactively identify and resolve design-related component or assembly challenges ensuring all components and subassemblies meet established performance specifications.

Define critical product design specifications based on clinical needs complete with formal justification and the development of associated test methods.

Develop and qualify design verification test procedures to assess critical quality attributes and product specifications.

Design and implement fixtures and methodologies for design and performance testing.

Author and execute comprehensive engineering protocols and reports to support all phases of Design Verification and Validation.

Author and maintain design-related documentation (MPIs SOPs work instructions test methods protocols and validation reports).

Partner with Regulatory and Quality to ensure all design processes meet FDA 21 CFR Part 820 ISO 13485 and ISO 14971 requirements.

Partner with Manufacturing and Process Development to ensure proper design transfer of catheter manufacturing processes from external contract manufacturers to internal operations.

Plan and execute design characterization and engineering DOEs to ensure consistency and scalability.

Perform/support root cause analysis and corrective actions (CAPA) to address product issues and supplier corrective actions (SCARs) where component-level issues impact design.

Support equipment selection and help define qualification (IQ/OQ/PQ) and preventive maintenance programs for verification equipment.

Collaborate with Quality and Regulatory to ensure DHF readiness for audits and inspections.

Identify continuous improvement opportunities for product performance reliability manufacturability and cost.

Qualifications

Bachelors degree in Mechanical Biomedical or related Engineering discipline.

5 years of hands-on product 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 is an onsite role in our Santa Clara CA office 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 $132000 - $178000 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 .

Required Experience:

Senior IC