PDS Tech Inc Product Engineer 2 in Flanders, New Jersey

PDS Tech Inc. is seeking a Product Engineer, in Flanders, NJ.

Summary:

  • In this role, the individual will develop test strategies, apply industry best practices, and self-manage to proactively drive and deliver testers to meet critical business milestones.

  • This individual must apply mechanical engineering principles towards test fixture design while incorporating FDA regulatory and site quality system requirements into the process activities and design elements.

  • The ability to synthesize multiple sources of business and technical requirements to produce an optimized solution is key.

  • A successful candidate will be able to effectively engage, influence, set priorities and manage the expectations of the cross-functional teams that provide inputs to the tester development process or are stakeholders of the finished product.

  • Create documentation packages and track the procurement of material.

  • 40% travel time to US and Global Mfg sites.

  • The candidate will need to coordinate and travel to various supplier and company development sites to meet key responsibilities.

Required Knowledge:

  • Mechanical Engineer - BSME with 2 - 5 years related experience.

  • Ability to interface with cross functional groups to develop testing systems for medical device manufacturing.

  • Ability to create and execute project schedules.

  • Ability and experience on project schedule reporting to management.

  • Ability to create testing device functional specifications and communicate specifications with hardware software developers.

  • Ability to read and create testing schematic diagrams.

  • Understanding of manufacturing process validation.

  • Experience in design and manufacturing in a new product development environment.

  • Experience in developing and implementing design of test and assembly fixtures.

  • Interface experience with R&D, Manufacturing, Supply Chain, Quality and Regulatory functions.

  • Excellent written, oral, planning and interpersonal communication skills with the ability to discuss or explain design features or issues with all level engineers, designers and drafters.

  • Can work independently in a fast paced new product development environment.

  • Highly self-motivated, self-directed, team orientated, and exceptionally attentive to detail.

  • Proactively resolves issues in a timely manner so that they do not affect project timelines.

  • Proficient current industry software and Microsoft Office.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.