Join a team that's building the world's first push-button combination drug product.

Company

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 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.
• $120,000 - $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