Senior Manufacturing Engineer (Medical Device)

Spirair, a venture capital backed medical device company, was co-founded by two Stanford Biodesign and Innovation fellows with a shared interest in optimizing outcomes and patient experience through innovation solutions. With a passion for developing elegant technologies that evolve care and enhance accessibility and effectiveness, the Spirair team is partnering with leading ENT advisors and industry veterans to offer treatment options that are both massively impactful and minimally invasive.

We are looking for a Sr. Manufacturing Engineer who will be responsible for manufacturing engineering functions to facilitate production of high-quality medical devices while achieving cost reductions milestones for assembly operations.

MAJOR DUTIES AND RESPONSIBILITIES

Develop new processes, write assembly instructions, and contribute to the new product development process by engaging in design for manufacturing (DFM).

Manage/execute manufacturing cost reductions and quality improvement programs by applying the principles of Six Sigma, material/demand flow, and lean manufacturing.

Write and execute validation plans and protocols of assembly processes/equipment (IQ, OQ, PQ).

Develop, evaluate, implement, and improve manufacturing methods, equipment and tooling.

Analyze space requirements, workflow, and design layout of equipment and workspace for maximum efficiency.

Work with internal stakeholders and suppliers to create specifications for equipment, materials, and components.

Estimate production rates, staffing requirements, and related costs to provide information for management decisions.

Apply statistical methods to characterize, troubleshoot, qualify, and validate processes or changes to existing components, equipment, or process settings.

Perform risk analysis activities, create and maintain pFMEA risk management files.

Complete project deliverables, monitor project schedules, and manage scope changes to assure team can meet delivery requirements.

Support manufacturing lines and key processes at suppliers, contract manufacturers, and internal manufacturing.

Problem solving with regards to products, components, equipment and systems.

Identify, develop, and implement new process methods, fixturing and technologies to achieve cost effectiveness and improved product quality.

Manage the design and fabrication of mechanical prototypes and models.

Review design change DCOs for manufacturing impact.

Actively participate in design transfers to production.

Review and approve supplier process controls.

Train and lead/supervise manufacturing technicians and assembly personnel.

Work directly with Quality in resolving non-conformances, deviations, and CAPAs that are related to manufacturing.

Other related duties as assigned.

Requirements

PREFERRED QUALIFICATIONS

Education and/or Job Experience:

Bachelor's degree in Engineering or equivalent.

5-10 years experience in manufacturing engineering, process development, and production, with working knowledge of Medical Device requirements.

Medical disposable device manufacturing experience highly desired.

Skills, Abilities, and Requirements:

Knowledge of ISO, GMP, and FDA requirements.

SolidWorks

Ability to multi-task and prioritize with flexibility required in a start-up environment.

Able to travel to suppliers and contract manufacturers (10-30%).

Proficient in Microsoft Word/Excel/PowerPoint.

Benefits

Spirair offers highly competitive salaries, equity, and benefits, including medical, dental, and vision insurance, paid time off, and 401(k). Legal authorization to work in the US is required. We are not able to sponsor individuals for employment visas for this job. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment verification form upon hire.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

The expected base salary range for this role is $130,000 - $150,000. Compensation will be based on a variety of factors, including experience, qualifications, and internal equity.

Qualification

Bachelor's Degree