Manufacturing Engineer

Company:

Pirouette is an innovative pharmaceutical company dedicated to developing high-quality, life-improving technologies that meet the highest standards of safety and efficacy. We operate under a robust Quality Management System compliant with ISO 13485, adhering strictly to design controls, risk management, and regulatory requirements to bring safe and effective products to market.

Pirouette's mission is to make selfcare with injectable medications simple, comfortable, and reliable, so patients can manage chronic conditions at home with confidence and fewer barriers. Pirouette is committed to reimagining the delivery of injectable medicines by focusing on patient comfort and confidence through intuitive design.

Job Summary:

We are seeking a proactive and detail-oriented Manufacturing Engineer to join our team. The ideal candidate will have 3-5 years of experience in medical device or pharmaceutical manufacturing, with a strong focus on lean manufacturing, process optimization, and reducing operational complexity. You will be responsible for improving manufacturing efficiency, attaining yield targets, and reducing cycle times on our production lines while ensuring strict compliance with regulatory standards (FDA/ISO).

This is a full‑time, onsite position.

Key Responsibilities

• Process Optimization: Analyze, develop, and optimize manufacturing processes and workflows to improve efficiency, yield, and throughput.
• Lean Manufacturing: Apply Lean Manufacturing tools (Kaizen, 5S, VSM, TPM) to identify bottlenecks, reduce waste, and improve operational flow.
• Yield & Cycle Time Improvement: Utilize time studies, line balancing, and root cause analysis to drive improvements in yield attainment and decrease production cycle times.
• Documentation & Compliance: Create and maintain standard work instructions, PFMEAs, process flow diagrams, and BOMs, ensuring compliance with FDA GMP, QSR, and ISO 13485 requirements.
• Validation: Support and lead process validation activities (IQ/OQ/PQ) for equipment and new product introductions to manufacturing.
• Troubleshooting: Provide daily production support, identifying root causes of manufacturing issues and implementing corrective/preventive actions (CAPA).
• Equipment & Layout: Evaluate and implement tooling, fixtures, and machinery to enhance production capabilities, including redesigning workstations for improved ergonomics and flow.
• Nonconformance & Investigation Support: Assist with and may lead root‑cause analysis and implementation of corrective/preventive actions (CAPA).
• Floor Support & Technical Oversight: Provide on-the-floor manufacturing/technical engineering support to manufacturing operations for combination products.

Qualifications:

Required

• Education: B.S. in Industrial Engineering, Mechanical Engineering, or a related engineering field.
• Experience: 3-5 years of manufacturing engineering experience within the medical device or pharmaceutical industry.
• Technical Skills: Proven experience with Lean Manufacturing, process optimization, and value stream mapping.
• Regulatory Knowledge: Strong knowledge of FDA 21 CFR Part 820 or 21 CFR 211 (GMP) and ISO 13485 standards.
• Software Systems: Proficiency in CAD software (SolidWorks) and associated PDM/PLM systems.
• Documentation: Experience creating PFMEA, Work Instructions, and process validation protocols.
• Automation: Experienced with performing needs assessments and justification for capital equipment expenditures, including semi-automated and fully-automated production systems; expertise with equipment IQ/OQ/PQ.

Preferred

• Six Sigma Green or Black Belt certification.
• Experience with ERP systems.

Working Conditions

• Frequent time spent in controlled manufacturing areas (cleanrooms, labs, and production lines).
• Ability to stand, walk, and perform manual tasks for extended periods.
• Some off-shift or weekend support may be required during development phases and and production demands.

What We Offer

• Competitive compensation and equity
• Benefits: Health, Dental, Vision, Basic Life and AD&D, 401(k) matching
• Paid Time Off: Discretionary
• Collaborative, mission‑driven startup culture

Location:

·       Portsmouth, NH

·       100% Onsite