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MillenniumSoft Inc

Staff Product Development Engineer - Onsite (Urgent Need)

MillenniumSoft Inc, Franklin Lakes, New Jersey, us, 07417

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Staff Product Development Engineer - Onsite (Urgent Need)

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MillenniumSoft Inc .

Position : Staff Product Development Engineer

Location : Franklin Lakes, NJ

Duration : 8 Months

Total Hours/week : 40.00

Shift : 1st Shift

Client : Medical Devices Company

Job Category : Engineering/Technical

Level of Experience : Senior Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Responsibilities and Qualifications

As part of the client Specimen Management business, the engineer in this role will be a key contributor on the R&D Team, specifically supporting the Specimen Acquisition Platform under the Enterprise Cost-To-Win (eCTW) program.

The individual in this position will have a complete understanding of a wide application of engineering principles, theories, concepts, and has a full knowledge and/or expertise of other related disciplines.

He/She will provide solutions that are imaginative, thorough, and practical to a wide range of complete problems.

He/she will be responsible for providing product development and engineering support by playing critical role in developing / integrating / analyzing / testing / and troubleshooting medical device/IVD components and systems relating to collection, preservation, manipulation and analysis of biological samples including human blood samples.

Works under general direction to guide design and development of advanced biomedical solutions that are needed to meet key business objectives relating to the existing and new medical device products.

Guides the successful completion of major programs and at times will function in a project leadership role.

Represents the organization as the prime technical contact on contracts and projects.

Interacts with senior external personnel on technical matters often requiring coordination between organizations.

Independently determines and develops approach to solutions.

Designs and develops in vivo and invitro models to evaluate product features and improvements.

Drives creative, logic and risk-based approaches to resolve technical challenges and tradeoffs under business constrains including strong capacity for critical thinking and analysis.

Independently determines and develops technical solutions to complex problems using sound engineering principles and design of experiments (DOE) while utilizing experimental, computational and/or analytical methods.

Develops robust test methods, design test fixtures and executes measurement system analysis.

Writes, implements, and leads hands-on benchtop studies, tolerance stack up analysis, design verification, validation, vendor interactions, material specifications, component specifications, troubleshooting and/or root-cause analysis in order to evaluate product performance & improvements.

Performs data analysis using statistical tools, generate reports and present recommendations to peers and business leaders.

Supports and at times lead material, design and/or process changes to existing products by following design control process and generating well-documented research and analyses records.

Demonstrate strong drive for results and clear accountability for successful and timely completion of designated tasks and projects.

Contribute to the development of new product development capabilities, methodologies and expertise by staying aware to trends in the computational and visualization technology fields and actively seek training to further improve skills.

Collects, records, reports, interprets, and analyzes data, presents results to peers and business leadership.

Provides advanced engineering skills and product evaluation support to the platform towards building business cases for new opportunities.

Contributes to development and implementation of R&D strategies through evaluation of new business opportunities, technologies, and possible acquisition targets.

Ensures compliance with client quality policies, procedures, and practices through appropriate communication, training and education of sound quality assurance principles.

Strength in scientific and engineering fundamentals based on first principles understanding including critical thinking and systematic problem solving skills as well as business acumen and learning agility are essential requirements to be successful in this position.

Strong technical judgement and leadership skills.

Demonstrated capability of leading R&D product development projects.

Experience in guiding team/individuals to develop technical solutions to complex problems.

R&D functional planning, requirement generation and technical (DFSS/Design/Cross functional) reviews for all product development phases.

Proficiency in solid CAD modeling (Creo, SolidWorks or equivalent) and design for manufacturability including injection molded and related systems and assemblies.

Product development considerations for tightly controlled, high-volume manufacturing process.

Disciplined in phase-gate product development and project planning.

Strong project management, prioritizing, and multi-tasking skills to work within tight eadlines.

Experience in directing associates and leading small cross-functional groups is a plus.

Proficiency with statistical methods including DoE and data analysis using software such as Minitab.

Proficiency with fixture design including basic machining considerations and developing test methods (fixture design and hands-on testing).

Understanding of Measurement Systems Analysis (MSA).

Proficiency with any of FEA and/or CFD modeling software is a plus.

Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies.

Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.

Strong creative, analytical, and problem solving skills required.

Good written and verbal communication skills.

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