The Principal Mechanical Engineer will lead and work on project teams to plan and support projects including the design, build, and test of next generation medical devices or significant improvements to existing products that are used by clinicians. The successful candidate will have deep technical capabilities in concept development, design, prototyping, testing, and intellectual property generation. They also will have shown the ability to lead and conduct research and development activities and exercise independent judgement to clarify and prioritize tasks to facilitate team decision making. They must also have demonstrated success at fostering relationships with internal stakeholders, external suppliers, and key opinion leaders.

Responsibilities:

• Lead and manage internal and external mechanical engineering resources in medical device development projects with minimal direction.
• Generate Project Plans and coordinate activities with product development teams, prioritize tasks and provide accurate project scheduling.
• Work with external industrial design teams and OEM manufacturers to develop electromechanical systems and sub-systems.
• Responsible for designing, building, and testing new concepts and iterating through the design process.
• Develop System Architectures through modelling, simulation, and empirical testing to design, develop, debug and test systems to meet required performance, focus on pneumatic systems with arrays of sensors and actuators.
• Perform written calculations and analytical modeling / analysis of new technologies in support of achieving product performance requirements.
• Perform mechanical analysis including Statics and Dynamics, Finite Element Modeling, and Material Properties
• Performs risk analyses using FMEA and fault tree methods. Work with other engineering disciplines (Mechanical, Electrical, and Software) to develop, implement, and verify system solutions for Class 3 medical devices (Safety critical).
• Evaluates product performance on an on-going basis and initiate and evaluate required changes to the design to improve and optimize performance
• Interfaces with internal and external clinicians, physicians and thought leaders to create innovative products and features
• Ensures adherence to product specifications, industry standards, and quality and regulatory procedures and requirements
• Maintains accurate documentation of concepts, designs, drawings, and processes
• Provides engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs
• Oversees outside vendors and consultants as required
• Works with manufacturing, marketing, and quality assurance staff to coordinate pilot production of our new products 

Requirements:

• BS or MS (preferred) in Mechanical Engineering
• 12 years experience developing and optimizing performance of Class 2 and/or Class 3 medical devices from concept through launch; experience with ventilators, pneumatic or hydraulic components and systems is required
• Strong analytical and leadership skills
• Expert in design of injection molded, machined, and sheet metal components.
• Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency
• Ability to work independently with high competency and little guidance.
• Strong foundation of mechanical engineering fundamentals and ability to perform detailed engineering analysis including tolerance analysis & FEA.
• Must be a creative problem solver that can think outside of the box to develop novel solutions to complex problems
• Prior project management experience
• Ability to search for appropriate technologies for conducting engineering concept feasibility to address product requirements and evaluate technology risk to a project‪‪
• Knowledge of statistical techniques for experimental design and data analyses
• Strong design control and documentation skills
• Good technical documentation skills including drawings, assemblies, BOMs, component specifications.
• Proficient computer skills with applicable software packages (e.g., Microsoft Office, Microsoft Power Point, etc.) and test data analysis packages (Minitab)
• Experience with prototyping (including 3D printing, manual machining, etc.)
• Working understanding of computational analysis (FEA, system modeling, etc.)
• Proficiency in tolerance analysis and descriptive statistics
• Ability to create and manage schedules for sub-tasks and work streams for which you are responsible
• Capable of identifying project risks and proactively developing mitigation plans
• Solid understanding of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485, related external standards, quality controls and manufacturing methods
• Significant experience with the complete lifecycle of development including conducting needs assessment and translating to requirements, concept and IP generation, technology development, detail design and manufacturing systems development, development of system/subsystem level requirements, risk management, fulfilling regulatory requirements, test method development, and product verification/validation
• Strong CAD skills are required.

Equal Opportunity Employer

Third Pole, Inc. provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

Reasonable Accommodations

The job summary, responsibilities and requirements listed above are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the responsibilities and skills required of this position. Reasonable accommodations may be made for any part of the application or interview process, and to enable qualified individuals with a medical condition or disability to perform the essential functions.