About role: Join Urology in the fast-paced world of acquisitions and integrations! The Urology Research & Development (R&D) organization is seeking a highly skilled and motivated R&D Engineer to join our team. In this role, you will provide support to assess design effectiveness of medical devices and evaluate compliance with requirements and international standards as part of an acquisition and integration of a third-party company. This role would be responsible for assessing the acquired company’s Design History File (DHF) and updating associated design documentation and design outputs to address any gaps against the Quality Management System.
Job responsibilities:
As a key team member, you will provide design solutions and technical support under some guidance of our subject matter experts. You will utilize your background in mechanical design, test method design and validation, verification testing and statistical analysis.
Testing products for feasibility, test method development and formal design verification testing
Providing input to project goals and progress and recommending appropriate revisions.
Communicating progress, risks, and trade-offs of technical deliverables to project leadership, and recommends revisions as needed.
Successfully completing engineering work in one or more of the following: technology development or remediation, product design refinement, test of materials, preparation of specifications, process study, and report preparation.
Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
Completing clear and concise engineering documentation.
Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables.
Required Qualifications:
Bachelor's degree or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
2+ yrs of engineering or related experience with bachelor’s degree; with MS degree, over 1 year of experience
Strong mechanical and problem-solving skills and attention to detail
Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills
Personal drive, individual accountability & a strong bias for action.
10% travel
Preferred Qualifications:
Experience with integrations and working with cross functional teams
Test Method development and validation experience
Experience in Minitab
Experience in single-use device Design Verification testing and data analysis
Ability to build strong relationships across the organization and with external stakeholders
Must Have:
Experience working on Medical Device DHF
Experience with formal testing and data logging of medical device/products
Experience with Instron or equivalent test equipment
Interviews - Teams video. 1 total interview with each candidate being interviewed, with manager and colleague.
Note:
Hybrid - minimum 3 days a week, with the expectation that it can be up to 5 days a week if tasks require it / Marl.
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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Numbers & Facts
Location
Marlborough, MA
Skills
Acquisition Integrationunmatched
Biomedical Engineeringunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Design Verificationunmatched
Detail Orientedunmatched
Documentationunmatched
Electromechanical Engineeringunmatched
Feasibility Analysisunmatched
Formal Verificationunmatched
Leadershipunmatched
Materials Testingunmatched
Mechanical Designunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Medical Productsunmatched
Minitabunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Product Designunmatched
Product Developmentunmatched
Product Testingunmatched
Quality Assurance Methodologyunmatched
Quality Managementunmatched
Regulatory Complianceunmatched
Requirements Managementunmatched
Research & Development (R&D)unmatched
Statisticsunmatched
Team Playerunmatched
Technical Deliveryunmatched
Technical Supportunmatched
Technical/Engineering Designunmatched
Test Dataunmatched
Test Designunmatched
Test Plan/Scheduleunmatched
Testingunmatched
Urologyunmatched
Validation Testingunmatched
Willing to Travelunmatched
Writing Skillsunmatched
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