Sr. Manufacturing Engineer

Position Title: Sr. Manufacturing Engineer Job Location: Fremont, CA

Department: Mfg Engineer Worker Category:Full Time

About QApel:

At QApel, were redefining neurovascular access with breakthrough technology that meets clinicians in their most critical moments, when seconds count. We develop and deliver cutting-edge access devices that solve real-world challenges in vascular intervention. Our fast-paced, high-growth environment thrives on innovation, collaboration, and bold thinking. Every team member here plays a vital role in transforming patient care and shaping the future of neurovascular treatment.

If youre passionate about technology that saves lives, and want your work to make a real difference, this is your team.

Who We Want:

We're looking for a Senior Manufacturing Engineer to drive the industrialization of our next-generation neurovascular devices. Youll be a key technical leader, working at the intersection of R&D, quality, and production to ensure our breakthrough designs are scalable, cost-effective, and flawlessly executed.

This is more than just a job, it's a chance to build something meaningful. Youll bring products from concept to commercial scale, helping accelerate time-to-market while upholding world-class quality standards.

What Youll Work On:

Lead design-for-manufacturability (DFM) efforts for new neurovascular/vascular products

Spearhead design transfer activities, ensuring seamless handoff from R&D to production

Develop and validate custom equipment, fixtures, and manufacturing processes that scale

Partner with suppliers and contract manufacturers to source critical components and capabilities

Lead protocol development and execution for design verification, validation, and process qualification

Troubleshoot complex manufacturing issues and implement data-driven solutions using Six Sigma and root cause analysis tools

Author and maintain documentation that meets FDA, ISO 13485, and global regulatory requirements

Drive CAPA investigations, NC resolution, and continuous process improvement in production

Act as a cross-functional leader, collaborating with Quality, R&D, Operations, and Regulatory to launch high-impact medical products

What You Bring:

Education & Background

Bachelors degree in engineering (masters degree preferred) or related field (or equivalent technical experience)

10+ years of experience in medical device manufacturing engineering, ideally in neurovascular or catheter-based technologies

Technical Skills

Expertise in design controls, validation, process development, and documentation within a regulated environment

Deep understanding of FDA regulations, ISO 13485, MDD/MDR, and global QMS standards

Skilled in CAD software (SolidWorks preferred), statistical process control, DOE, and Six Sigma tools

Leadership & Execution

Track record of leading cross-functional projects from concept through commercialization

Strong verbal/written communicator with the ability to influence across all levels

Agile problem-solver who thrives under pressure in dynamic environments

Willingness to travel periodically to suppliers, partners, and contract manufacturers

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly. After you join the company, your performance, contributions, and results, along with business and organizational need,s will affect your base salary. The base salary range for this full-time position is between $130,000 to $150,000 + equity + benefits.

Compensation details: 00 Yearly Salary

PI85bebb02bb02-2732

Permanent