Mechanical Engineer

Job Description

Job Description

SUMMARY

The Mechanical Engineer must have experience designing customer-facing finished electronic / mechanical assemblies, plastic enclosures and parts from scratch to meet requirements set by Marketing department. With regards to this position, the Mechanical Engineer is responsible for all aspects of the continuous improvement of PTS Products which support Quality. The Mechanical Engineer works collaboratively with other engineers and scientists but is able to function independently with minimal oversight.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Design and test mechanical assemblies in development and support of PTS Products.
• Prepare designs for successful transfer to manufacturing using DFMA principles.
• Practice DFx methodologies to ensure reliability, quality, and repeatability.
• Support the PTS Quality system as necessary through the planning and execution of CAPA, NCR, quality audits, customer return analysis, and other processes as required.
• Liaise with external organizations to advance product development.
• Prepare assay validation reports and other assay-related documentation as required by FDA regulations.
• Conducts experiments to test system performance which may include architecture and / or analyzer issues relating to new product design and development activities.
• Provide team leadership for designated personnel assigned to specific projects by Senior Management.
• Keeps Senior Management informed about the status of on-going projects.
• Actively collaborate, build and leverage relationships across functional teams to achieve established shared goals or objectives, partnering with team members to develop key tasks and project plans for timely completion of goals.

QUALIFICATIONS

EDUCATION and / or EXPERIENCE

QUALITY COMMITMENT

This position requires compliance to applicable quality system and regulatory requirements. This individual adopts a “quality in everything we do” approach to all aspects of the execution of responsibilities of this position. Through vigilance, this individual remains alert to any potential compliance situations, and must report such observations to managers and the Head of Quality.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Ability to sit for prolonged periods of time, handling, typing, talking, listening, requiring clear near and midrange vision in connection with performing essential functions.

EQUAL OPPORTUNITY EMPLOYER :  PTS Diagnostics is an Equal Opportunity and E-Verify employer. Employment decisions for all applicants and employees will be made without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, age, national origin, marital status, veteran status, disability, or other characteristics protected under local, state or federal law.

STATEMENT of OTHER DUTIES DISCLAIMER

This Job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and to perform any other duties requested by his or her supervisor.

Company Description

PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success : People, Technology and Service.

Company Description

PTS Diagnostics is an innovative point-of-care diagnostics solutions provider that partners with patients and healthcare professionals to provide the right information at the right time to make the right decisions. The company’s name represents the three pillars upon which it has built its long-term success : People, Technology and Service.