Process Development Engineer

Process Development Engineer

Status: Full-time Exempt

Reports to: Sr. Director of R&D

Location: Onsite Santa Clara CA

About the Role

VahatiCor a T45 Labs portfolio company is seeking a hands-on Process Development Engineer with strong catheter device experience deep process development expertise and a track record of building scalable compliant manufacturing processes. The engineer will collaborate closely with R&D Quality and Manufacturing to establish robust processes equipment and documentation in a fast-paced startup environment.

Key Responsibilities

Oversee supplier performance and relationships to guarantee consistent delivery of high-quality components materials and finished goods.

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

Design and implement fixtures and methodologies for product testing and manufacturing processes.

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

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

Partner with R&D and Quality to ensure all processes meet FDA 21 CFR Part 820 ISO 13485 and ISO 14971 requirements.

Lead 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.

Develop optimize and validate manufacturing processes including equipment tooling and fixtures.

Perform/support root cause analysis and corrective actions (CAPA) to address manufacturing issues and supplier corrective actions (SCARs) to address issues at the supplier.

Qualifications

Bachelors degree in Mechanical Biomedical or related Engineering discipline.

3-5 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 legally authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor H-1B visas.

Location & Compensation

This is an onsite role based in Santa Clara CA and is open to candidates living within a reasonable commuting distance of our office. There is no relocation package available.

T45 Labs is committed to fair and equitable pay practices and compensation may include bonuses equity and benefits as part of the total rewards package.

The anticipated salary range of this position is $115000 - $155000 annually based on San Francisco Bay Area market data. Actual compensation will vary depending on factors such as years of experience and skills.

Equal Employment Opportunity Statement

T45 Labs and its affiliated companies are Equal Opportunity Employers. 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 property of T45 Labs and/or its affiliated companies 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