PDS Tech Inc Product Engineer 2 in Newark, Delaware
PDS Tech, Inc. is seeking a Product Engineer 2, in Newark, DE.
Supports the semi-complex planning of detailed product development objectives.
Participates in the preparation of semi-complex sketches, design layouts, and other specifications.
Provides support in semi-complex review of results to determine that products perform in the intended manner.
Participates in preparing semi-complex prototypes for testing and provides technical assistance on design feasibility.
Assists in standardizing semi-complex materials, components and assemblies.
Participates in maintaining detailed and comprehensive records of all inventive ideas, designs, and basic improvements.
Provides support in documenting product issues for future reference and problem resolution.
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
20% travel time to US and Global Mfg sites
Required Knowledge/Skills, Education, and Experience
Electrical Engineer - BSEE 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.