Product Engineer II

POSITION SUMMARY

The Product Engineer II is responsible for the development of new products and support of existing products. This position takes cross functional inputs (Marketing, Quality and Supply Chain) and develops solutions to bring product ideas to realization. The Product Engineer II will manage key projects with metrics for product performance, project cost and project timing. This position works closely with Quality to verify that new products and product changes meet the appropriate requirements. The Product Engineer II may train, assist, and periodically oversee some of the activities of the Product Engineer I.

Essential Functions Statements

§ Design electromechanical and thermoplastic consumer products and medical devices that meet safety, regulatory, quality, reliability, and manufacturability requirements

§ Work with cross-functional teams to develop and implement new products, cost reductions and product improvements

§ Communicate with domestic and foreign suppliers (particularly in China, Thailand and/or Mexico)

§ Create and maintain product specifications to meet cGDP (current Good Documentation Practices)

§ Plan, execute and document Engineering Change Orders

§ Perform internal QMS audits to ensure compliance with regulations and conformance to standards

§ Perform related duties as required

POSITION QUALIFICATIONS

Competency Statements

§ Relationship Building - Ability to effectively build relationships with customers and co-workers and maintain a positive work atmosphere by working in a cooperative manner treating all individuals with respect and dignity.

§ Leadership Skill- Ability to lead and direct the activities of less experienced engineers.

§ Technical Aptitude - Ability to comprehend complex technical topics and specialized information.

§ Conceptual Thinking - Ability to think in terms of abstract ideas.

§ Analytical Skills - Ability to use thinking and reasoning to solve a problem.

§ Communication, Written - Ability to communicate in writing clearly and concisely.

§ Deductive Reasoning - Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

§ Detail Oriented - Ability to pay attention to the minute details of a project or task.

§ Creative - Ability to think in such a way as to produce a new concept or idea.

§ Organized - Possessing the trait of being organized or following a systematic method of performing a task.

§ Research Skills - Ability to design and conduct a systematic, objective, and critical investigation.

§ Initiative - Ability to make decisions or take actions to solve a problem or reach a goal.

§ Customer Oriented - Ability to take care of the customers’ needs while following company procedures.

§ Innovative - Ability to look beyond the standard solutions.

Skills & Abilities

Education:

Bachelor's Degree Required, Field of Study: Mechanical or Biomedical Engineering

Experience:

§ 3-5 years of relevant industry experience is required

§ Consumer product development experience is required

§ Project management experience required. Must understand a phase-gate product development process

§ Cross-functional team leadership experience is required

§ Experience designing thermoplastic parts is required

§ Quality Management System (ISO 13485, 21 CFR 820 and/or ISO 9001) experience is desired

§ Demonstrated understanding of good manufacturing practices (cGMP) and proper document control (cGDP) is desired

§ Experience designing products to meet regulatory and product safety standards (FDA, CPSC, UL, CSA, NOM, IEC, etc.) is desired

§ Experience with IEC 60601-1 requirements is desired

§ Pneumatics, electro-mechanical control systems, and/or electronics experience is desired

§ Global supplier experience is desired

Computer Skills:

§ Demonstrated mastery of 3D solid modeling (preferably SolidWorks)

§ Proficient with Microsoft Office Suite

§ Proficient with Microsoft Project

Travel Required:

5-10%

Reports To:

Director of Engineering

Looking for a highly motivated and talented engineer. You must want to work in a fast-paced, entrepreneurial company. You must be a self-starter, be curious, and have a growth mindset.