Senior Manufacturing Engineer

Job Summary

Spiro Robotics is seeking a Senior Manufacturing Engineer to support the next phase of company growth as we transition from pre-commercial development to commercial-scale manufacturing.

This role will lead New Product Introduction (NPI), manufacturing line transfer, process validation, and sustaining manufacturing engineering activities for FDA Class II medical devices. The Senior Manufacturing Engineer will own the transfer, validation, and optimization of disposable and electromechanical products to global contract manufacturing partners, ensuring robust, compliant, scalable, and cost-effective production processes.

The ideal candidate has deep experience in medical device manufacturing, contract manufacturing, IQ/OQ/PQ validation, Design for Manufacturing and Assembly (DFMA), supplier quality, and cross-functional collaboration in a fast-paced startup environment.

Key Responsibilities

NPI and Manufacturing Engineering

• Lead end-to-end NPI and sustaining manufacturing engineering activities, including technology transfer from R&D to production.
• Serve as the technical lead and primary manufacturing interface with international contract manufacturing partners.
• Develop and execute manufacturing strategies aligned with Design Controls, Quality System Regulations, ISO 13485, and commercialization timelines.
• Lead DFMA initiatives to improve product yield, manufacturing throughput, assembly efficiency, and cost of goods sold.
• Support change control, supplier qualification, quality agreements, and manufacturing readiness activities.

Manufacturing Line Transfer

• Lead the transfer of single-use disposable devices and electromechanical systems to contract manufacturers in Germany.
• Act as the main point of contact between the California-based team and international manufacturing partners.
• Support manufacturing line setup, equipment readiness, documentation transfer, operator training, and production ramp activities.
• Troubleshoot manufacturing issues, identify root causes of production failures, and implement corrective actions to minimize downtime and improve yield.

Design for Manufacturing

• Partner with contract manufacturers to identify opportunities to reduce COGS, improve process capability, and scale production efficiently.
• Collaborate with R&D to drive design changes that reduce assembly time, improve manufacturability, and increase production yield.
• Evaluate timing and business justification for investments in production tooling, fixtures, automation, and capital equipment.

Process Validation

• Collaborate with R&D and Quality teams to develop and maintain pFMEAs for manufacturing processes.
• Author and maintain the Master Validation Plan for single-use devices and IQ/OQ/PQ process validation.
• Conduct on-site visits to contract manufacturers to oversee process validation execution and resolve validation-related issues.

Process Development and Manufacturing Readiness

• Design, qualify, and implement assembly fixtures, inspection methods, test methods, and manufacturing controls.
• Define and maintain inspection criteria for incoming materials, in-process checks, and finished goods.
• Ensure contract manufacturing partners build products in accordance with internal quality standards, specifications, and approved procedures.
• Support continuous improvement activities to improve manufacturability, quality, and production efficiency.

Incoming Inspection

• Perform incoming inspection of received materials and components.
• Verify that incoming materials meet defined specifications and include the required documentation, certifications, and quality records.
• Identify, document, and escalate material nonconformances as appropriate.

Supplier Quality and Compliance

• Partner with the Quality team to support supplier audits, Supplier Corrective Action Requests, nonconformances, and manufacturing-related quality processes.
• Support supplier performance monitoring, issue resolution, and corrective/preventive actions.
• Ensure manufacturing processes remain compliant with applicable medical device regulations, internal procedures, and quality system requirements.

Required Qualifications

• 7+ years of manufacturing engineering, process engineering, or related experience in the medical device industry; Class II medical device experience preferred.
• Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related technical field.
• Proven experience leading NPI transfers to external contract manufacturers.
• Strong understanding of statistical methods used in process validation and manufacturing process capability.
• Hands-on experience writing and executing IQ/OQ/PQ protocols in regulated medical device environments.
• Working knowledge of 21 CFR Part 820, ISO 13485, Design Controls, and medical device quality system requirements.
• Experience supporting FDA audits or working within manufacturing processes that have successfully passed FDA audits.
• Ability and willingness to travel internationally to Germany up to 30% during peak transfer phases.
• Strong troubleshooting, root cause analysis, documentation, and cross-functional communication skills.

Preferred Qualifications

• Experience with Arena or similar eQMS platforms.
• Experience with sterile packaging validation, including ISO 11607.
• Experience with high-volume plastic disposables, including bonding, molding, packaging, and inspection processes.
• Experience with electromechanical capital equipment, including cable harnesses, software/electrical test methods, and system debugging.
• Ability to read electrical schematics well enough to troubleshoot cable harness issues.
• Experience designing or qualifying manufacturing fixtures, test methods, and inspection systems.
• Prior project management experience, including ownership of schedules, milestones, risks, and cross-functional deliverables.
• Prior startup experience or experience working in a fast-paced, resource-constrained environment.
• Strong teamwork, communication, ownership, and execution skills.
• Demonstrated ability to overcome obstacles, meet deadlines, and jump in wherever needed to support company goals.

Ideal Candidate Profile

The ideal candidate is a hands-on manufacturing engineer who can move comfortably between the design team, quality system, production floor, and contract manufacturing partners. This person understands how to scale medical device manufacturing from development builds to validated commercial production and can balance technical rigor, regulatory compliance, cost, schedule, and practical execution.