Senior Engineer, R&D - Mechanical Design

About the role

Research, design, develop, modify, and verify mechanical components and modules for medical devices with minimal supervision. Translate design inputs into engineering specifications and produce subsystem-level designs. Prototype and analyze design solutions to validate concepts and performance. Apply advanced engineering principles to solve complex technical challenges. Create and refine engineering documentation, including Design History Files, in compliance with design control procedures. Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management teams. Understand product use and clinical procedures to inform design strategy and decisions. Support regulatory compliance by following industry standards, risk management, and quality system requirements.

Responsibilities

• Research, design, develop, modify, and verify mechanical components and modules for medical devices with minimal supervision.
• Translate design inputs into engineering specifications and produce subsystem-level designs.
• Prototype and analyze design solutions to validate concepts and performance.
• Apply advanced engineering principles to solve complex technical challenges.
• Create and refine engineering documentation, including Design History Files, in compliance with design control procedures.
• Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management teams.
• Understand product use and clinical procedures to inform design strategy and decisions.
• Support regulatory compliance by following industry standards, risk management, and quality system requirements.

Requirements

• Bachelor of Science in Engineering, Mechanical Engineering, or Biomedical Engineering.
• Minimum 2 years of relevant work experience.

Preferred Qualifications

• Proficiency in mechanical engineering practices and design principles.
• Ability to create engineering drawings and models using GD&T and CAE tools.
• Knowledge of materials and manufacturing processes.
• Familiarity with CAD tools (e.g., SolidWorks, Creo).
• Experience communicating technical plans and information to cross-functional teams.

Skills

• Advanced engineering principles.
• GD&T and CAE tools proficiency.
• Materials and manufacturing processes knowledge.
• CAD tools familiarity (e.g., SolidWorks, Creo).
• Technical communication skills.

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Pay

$77,700 - $129,500 USD Annual

Schedule

3 days a week in the office, can work from home on other days.