Mechanical Design Engineer II / Product Development Engineer II

Company Pirouette is an innovative pharmaceutical company dedicated to developing high-quality, life-improving technologies that meet the highest standards of safety and efficacy. Pirouette's mission is to make selfcare with injectable medications simple, comfortable, and reliable so patients can manage chronic conditions with confidence and fewer barriers at home or on the go. 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 talented Mechanical Design Engineer II to play a key role in the design, development, verification, and validation of mechanical and electromechanical medical devices. This position requires strong technical skills in mechanical design with a focus on plastic components and assemblies, combined with a solid understanding of medical device regulations. The ideal candidate will contribute independently on projects while collaborating closely with senior engineers and cross-functional teams to deliver high-quality, manufacturable, and patient-safe products. Key Responsibilities

• Design, build, integrate, and commission semi-automated assembly and test stations, including mechanical structures, fixtures, guarding, sensors, actuators, controls, and operator interfaces.
• Develop and troubleshoot machine-control solutions using Arduino, PLCs, or similar platforms, including basic electrical schematics, component selection, wiring, programming, and system integration.
• Prepare equipment specifications and manage external suppliers as needed, while retaining technical ownership of station design, assembly, debugging, documentation, and transfer into manufacturing
• Design and develop plastic components and assemblies (injection-molded parts, housings, fluid paths, and multi-component mechanisms) for medical devices.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to create cost-effective, high-volume production-ready designs.
• Participate in risk management activities per ISO 14971, including hazard analysis, FMEA, and implementation of risk controls.
• Support design verification and validation activities, including protocol development, testing, and report generation.
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes under the guidance of senior engineers.
• Perform tolerance analysis, material selection (biocompatible plastics), and basic finite element analysis (FEA).
• Contribute to Design History Files (DHF), technical documentation, and regulatory submissions.
• Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, and Clinical teams to support design transfer and scale-up.
• Conduct statistical analysis to support process capability, design verification, and continuous improvement initiatives.
• Identify and implement design improvements while maintaining compliance with ISO 13485, cGMP, and ISO 11608 requirements.
• Support junior engineers and designers as needed and contribute to a collaborative team environment.

Qualifications & Experience Required:

• Bachelor’s degree in Mechanical Engineering or a related technical discipline (Master’s preferred).

• Minimum 5–8 years of progressive experience in mechanical/product design engineering, with at least 3 years specifically in the medical device industry.

• Strong hands-on experience designing plastic components for medical devices (injection molding, insert molding, and assemblies).

• Working knowledge of: cGMP (21 CFR Part 820) • ISO 13485 (Quality Management Systems)

• ISO 14971 (Risk Management)

• ISO 11608 (Needle-based injection systems)

• Electrical and/or automation experience with related technical and software skills having shifted manual activities to semi-automated and then to automated

• Experience supporting IQ/OQ/PQ validation activities.

• Proficiency with 3D CAD software (SolidWorks strongly preferred) and PDM/PLM systems.

• Solid understanding of design controls, tolerance analysis, and statistical tools (SPC, capability studies).

• Strong problem-solving, communication, and teamwork skills

Preferred Skills:

• Prior experience designing autoinjectors, pen injectors, or other prefilled syringe-based delivery systems.
• Experience with Lean Manufacturing or Six Sigma methodologies.
• Familiarity with automation systems or basic PLC programming.
• Knowledge of biocompatibility standards (ISO 10993) and sterilization methods.
• Previous experience in drug delivery or combination products (auto-injectors, pen injectors, etc.).

Location:

• Portsmouth, NH
• 100% Onsite

Compensation and Benefits We offer a highly competitive total compensation package, highlighted by our comprehensive, 100% company-paid benefits program — with no employee contribution required for medical, dental, or vision coverage for employees and their eligible dependents.

• Comprehensive Health, Dental, and Vision Insurance – 100% paid by the company for you and your dependents.
• 401(k) Plan with up to 4% company match.
• $110,000 - $130,000 /yr base salary + potential for performance bonus.
• Discretionary Time Off Policy (DTO), Holidays + Company Holidays
• Professional development opportunities, including conferences, training
• Stock Option Potential Pending Experience