Pirouette Pharma

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

About Pirouette Pharma Pirouette's mission is to make self‑care with injectable medications simple, comfortable, and reliable—so patients can manage chronic conditions at home with confidence and fewer barriers. Position Summary The Manufacturing Line Quality Engineer will provide day to day quality support for production lines that manufacture combination products. This role is primarily floor-facing and ensures that materials, in process activities, equipment, and final products meet Pirouette Pharma’s standards for safety, quality, and compliance. The ideal candidate is detail oriented, proactive, and thrives in a dynamic manufacturing environment. Key Responsibilities Floor Support & Quality Oversight Provide on-the-floor quality engineering support to manufacturing operations for combination products. Perform and document line clearances prior to batch start, product changeovers, and as required throughout production. Ensure labeling control requirements are met. Incoming & In‑Process Quality Control Conduct incoming inspection of components and materials (visual, dimensional, and functional tests as applicable). Support in‑process quality checks to ensure compliance with approved procedures and specifications. Final Device Testing Execute and document final device testing per established test methods and quality standards. Troubleshoot and escalate any issues identified during testing. Documentation & Batch Record Review Perform batch record reviews (BRR) for completeness, accuracy, and GMP compliance. Ensure timely resolution of discrepancies or data integrity concerns. Nonconformance & Investigation Support Initiate, support, and document nonconformance reports and associated investigations. Quarantine nonconforming materials as required. May assist root cause analysis and implementation of corrective/preventive actions (CAPA).  Calibration & Equipment Quality Checks May administer calibration program and ensure timely calibration of Pirouette equipment either in-house or via approved vendors. Perform periodic calibration of designated gauges, fixtures, and test equipment. Maintain accurate calibration documentation and support equipment related quality investigations. Compliance & Continuous Improvement Ensure that all work adheres to applicable cGMP, ISO, and FDA regulatory requirements for combination products. Participate in continuous improvement initiatives to enhance product quality and operational efficiency. Additional Responsibilities Support audits, change controls, validation activities, and cross functional quality initiatives as needed. Perform other duties as assigned by leadership. Qualifications Required Bachelor’s degree in Engineering, Life Sciences, or a related technical field — or equivalent practical experience. 2-4 years prior experience in a regulated manufacturing environment (pharma, medical device, or combination products preferred). Strong attention to detail, organizational skills, and documentation accuracy. Ability to work effectively on the production floor in a fast-paced environment. Basic understanding of quality systems, cGMP, and data integrity principles. Preferred Experience with combination product manufacturing, device assembly lines and/or cleanroom experience. Familiarity with root-cause analysis tools (5 Whys, Fishbone, etc.). Familiarity with Lean manufacturing principles. Hands‑on experience with inspection, measurement tools, or test equipment. Knowledge of FDA 21 CFR Part 4, 210, 211 and 820, ISO 13485, or similar regulatory standards. 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 investigations or production demands.

Company: Pirouette is an innovative pharmaceutical company focused on developing high-quality, life-improving technologies that meet the highest standards of safety and efficacy. We operate within a robust Quality Management System that is compliant with ISO 13485 and grounded in rigorous design controls, risk management, and regulatory discipline to bring safe and effective products to market.   Pirouette's mission is to make self-care with injectable medications simple, comfortable, and reliable so patients can manage chronic conditions at home with greater confidence and fewer barriers. We are reimagining the delivery of injectable medicines through intuitive design and a deep commitment to the patient experience.   Job Summary: We are seeking an experienced, hands-on Supply Chain Manager to lead global sourcing, supplier performance, procurement execution, and inventory oversight for complex medical device components and subassemblies. This role is responsible for ensuring critical materials and services are sourced, tracked, and delivered on time to support final assembly, qualification, testing, and key company milestones. The ideal candidate is exceptionally self-motivated, energized by a fast pace, and comfortable operating with a high degree of ownership and urgency in a startup environment. They should be a strong relationship builder who can engage confidently and effectively with supplier teams at all levels, whether in virtual settings or in person. This is a full-time, onsite position based in Portsmouth, New Hampshire.   Key Responsibilities Supplier Management & Strategic Sourcing ·        Serve as the main point of contact and owner of relationships with suppliers, CDMOs, component manufacturers, and service providers ·        Maintain Approved Supplier List (ASL) compliance and oversee supplier onboarding, evaluation, and re-evaluation ·        Develop strong partnerships with domestic and global suppliers to support a high-performing supplier network ·        Lead supplier sourcing and contract coordination ·        Manage day-to-day supplier communications to ensure responsiveness, accountability, and accurate commit dates ·        Travel domestically and/or internationally to supplier facilities for audits, business reviews, and relationship management ·        Resolve critical supplier escalations quickly and support supplier audits in partnership with Quality ·        Manage supplier nonconformance resolution and proactively identify and qualify backup suppliers to mitigate supply risk Procurement & Order Execution ·        Own the end-to-end process from procurement through receipt of materials ·        Perform daily tracking of open purchase orders and deliveries ·        Secure accurate supplier commit dates and monitor purchase order and material commit performance against plan ·        Ensure alignment with project timelines, manufacturing schedules, final assembly, qualification, and testing needs ·        Actively follow up on open orders and escalate delays, shortages, and risks early, including maintaining published recovery action plans ·        Resolve discrepancies, including delivery issues, quality concerns, and invoicing mismatches ·        Ensure on-time delivery to production and that procured parts meet exact specifications Inventory & Materials Management ·        Build and maintain inventory tracking for materials, components, and finished goods where applicable ·        Integrate and manage supply chain data, metrics, and transactional workflows within the ERP ·        Establish reorder points and maintain appropriate safety stock levels ·        Prevent stockouts and excess inventory through proactive planning ·        Coordinate closely with technical, manufacturing, project management, quality, and finance teams on demand and readiness needs Operational Readiness & Cross-Functional Support ·        Support clinical and manufacturing readiness by ensuring material availability for