MillenniumSoft Inc ยท 3 weeks ago
Senior Staff Product Development Engineer - Onsite
Franklin Lakes, NJ
Full-time
Onsite
Senior Level, Lead/StaffMillenniumSoft Inc is a Medical Devices Company, seeking a Senior Staff Product Development Engineer to contribute to the R&D Team focused on the Specimen Acquisition Platform. The role involves providing product development and engineering support, developing and integrating medical device components, and ensuring compliance with quality policies while leading projects and technical solutions.
Staffing & Recruiting
No H1B
Responsibilities
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
Qualification
Required
Complete understanding of a wide application of engineering principles, theories, concepts, and full knowledge and/or expertise of other related disciplines
Ability to provide solutions that are imaginative, thorough, and practical to a wide range of complete problems
Experience in providing product development and engineering support for medical device/IVD components and systems
Ability to guide design and development of advanced biomedical solutions
Experience in leading major programs and functioning in a project leadership role
Ability to interact with senior external personnel on technical matters
Independently determines and develops approach to solutions
Experience in designing and developing in vivo and invitro models to evaluate product features and improvements
Ability to drive creative, logic and risk-based approaches to resolve technical challenges
Experience in developing technical solutions to complex problems using sound engineering principles and design of experiments (DOE)
Ability to develop robust test methods, design test fixtures and execute measurement system analysis
Experience in writing, implementing, and leading hands-on benchtop studies, tolerance stack up analysis, design verification, validation, vendor interactions, material specifications, component specifications, troubleshooting and/or root-cause analysis
Experience in performing data analysis using statistical tools, generating reports and presenting recommendations
Ability to support and lead material, design and/or process changes to existing products
Demonstrated strong drive for results and accountability for successful and timely completion of tasks and projects
Experience in contributing to the development of new product development capabilities and methodologies
Ability to collect, record, report, interpret, and analyze data, and present results
Experience in providing advanced engineering skills and product evaluation support
Ability to contribute to development and implementation of R&D strategies
Ensures compliance with client quality policies, procedures, and practices
Strength in scientific and engineering fundamentals based on first principles understanding
Strong technical judgement and leadership skills
Demonstrated capability of leading R&D product development projects
Experience in guiding teams/individuals to develop technical solutions to complex problems
Experience in R&D functional planning, requirement generation and technical reviews for all product development phases
Proficiency in solid CAD modeling (Creo, SolidWorks or equivalent) and design for manufacturability
Experience with 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
Experience in directing associates and leading small cross-functional groups
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
Understanding of Measurement Systems Analysis (MSA)
Proficiency with any of FEA and/or CFD modeling software
Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies
Ability to effectively and clearly communicate concepts, ideas and knowledge
Strong creative, analytical, and problem solving skills
Good written and verbal communication skills
Preferred
Experience in directing associates and leading small cross-functional groups is a plus
Proficiency with any of FEA and/or CFD modeling software is a plus
Company
MillenniumSoft Inc
Hire us to hire for you Staffing is not a straightforward activity.
Founded in 1999
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sailaja Mashetty
Partner - Customer Sucess
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