Staff Manufacturing Engineer

Synova Partners Limited; San Francisco (CA); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Competitive pay

Equity opportunities

Health benefits

401(k) contributions

Paid time off

Job summary

Synova Partners is partnering with a cardiovascular startup preparing for commercial launch and is seeking a Staff Manufacturing Engineer to lead early development and scale catheter manufacturing. You will own production processes, validate and scale, and drive yield, quality, and cost improvements across multiple lines.

The role includes mentoring engineers and collaborating with suppliers in a fast-paced environment.

Qualifications

• Bachelor’s degree in engineering is required.
• 8+ years of medical device manufacturing experience.
• Hands-on catheter manufacturing experience preferred.
• Strong experience with process validation, DOE and SPC.
• Working knowledge of medical device quality systems.

Responsibilities

• Develop, validate, and scale catheter manufacturing processes, equipment, tooling, and fixtures.
• Own key production processes, resolve issues, and improve yield, throughput, quality and cost.
• Lead IQ/OQ/PQ, design of experiments (DOE), and root cause investigations.
• Collaborate with cross-functional teams and equipment suppliers to improve manufacturability and expand capacity.
• Maintain risk assessments and quality documentation while training and mentoring engineers, technicians, and assemblers.

Skills

Process validation

DOE

SPC

Root cause analysis

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Job description

Synova Partners is working with a well-funded, highly disruptive cardiovascular startup that is redefining catheter-based therapies by bringing the precision and control of surgery to minimally invasive procedures. They are currently scaling up production, expanding their team, and preparing for commercial launch.

Position Overview

The Staff Manufacturing Engineer will be a core team member of their growing manufacturing/process development team, leading early development of novel manufacturing processes and paving the way for scale-up to commercial launch. Additionally, the engineer will oversee, troubleshoot, and improve existing production processes. This role will be involved in multiple production lines and support the manufacturing engineering and operations teams.

Responsibilities

• Develop, validate, and scale catheter manufacturing processes, equipment, tooling, and fixtures to support commercialisation.
• Own key production processes, resolve manufacturing issues, and improve yield, throughput, quality, and cost.
• Lead process validation (IQ/OQ/PQ), design of experiments (DOE), and root cause investigations.
• Collaborate with cross-functional teams and equipment suppliers to improve manufacturability and expand production capacity.
• Maintain risk assessments and quality documentation while training and mentoring engineers, technicians, and assemblers.

Qualifications

• Bachelor’s degree in engineering and at least 8 years’ experience in medical device manufacturing.
• Catheter manufacturing experience strongly preferred, with hands‑on expertise in equipment, tooling, and fixture development.
• Strong experience in process validation, root cause analysis, and statistical methods, including DOE and SPC.
• Working knowledge of medical device quality systems and regulatory requirements.
• Ability to independently lead technical projects, make sound decisions, and manage changing priorities in a fast‑paced environment.

Why Join?

• Help bring innovative catheter technology to patients as the company scales towards commercialisation.
• Join a collaborative, growing team with meaningful technical ownership and opportunities for professional development.
• Competitive compensation, performance incentives, and equity opportunities.
• Comprehensive health benefits, a 401(k) with employer contributions, and generous paid time off.