Sunrise Systems, Inc. ยท 3 weeks ago
Staff Engineer - Product Development - Medical Devices
Franklin Lakes, NJ
Full-time
Onsite
Lead/Staff
$65/hr - $68/hrSunrise Systems, Inc. is a leading Medical Devices Manufacturing Company seeking a Staff Engineer for Product Development in Medical Devices. The role involves providing engineering support for medical device components, focusing on product development, testing, and troubleshooting related to biological sample management.
Information Technology & Services
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
Qualification
Required
Complete understanding of a wide application of engineering principles, theories, concepts
Full knowledge and/or expertise of other related disciplines
Provide solutions that are imaginative, thorough, and practical to a wide range of complete problems
Responsible for providing product development and engineering support
Guide design and development of advanced biomedical solutions
Guide the successful completion of major programs
Function in a project leadership role
Represent the organization as the prime technical contact on contracts and projects
Interact with senior external personnel on technical matters
Independently determine and develop approach to solutions
Design and develop in vivo and invitro models to evaluate product features and improvements
Drive creative, logic and risk-based approaches to resolve technical challenges
Independently determine and develop technical solutions to complex problems
Develop robust test methods, design test fixtures and execute measurement system analysis
Write, implement, and lead hands-on benchtop studies
Perform data analysis using statistical tools, generate reports and present recommendations
Support and lead material, design and/or process changes to existing products
Demonstrate strong drive for results and clear accountability
Contribute to the development of new product development capabilities
Collect, record, report, interpret, and analyze data
Provide advanced engineering skills and product evaluation support
Contribute to development and implementation of R&D strategies
Ensure 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 team/individuals to develop technical solutions
R&D functional planning, requirement generation and technical reviews
Proficiency in solid CAD modeling (Creo, SolidWorks or equivalent)
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
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
Benefits
ACA compliant medical coverage
Dental insurance
Vision insurance
Sick time benefits as required per State regulations
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
Founded in 1990
501-1000 employees
H1B Sponsorship
Sunrise Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
Company data provided by crunchbase