Assoc R-D Engineer - Exempt

LanceSoft Inc

Boulder, CO

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Analysis Skills, Budgeting, Business Skills, Code of Federal Regulations, Communication Skills, Conflict Resolution, Cross-Functional, Design Verification, Detail Oriented, Electrical Components, Electricity, Engineering, Entrepreneurship, FDA Requirements, Help Desk, International Electro-Technical Commission (IEC), Marketing Communications, Mechanical Engineering, Medical Equipment, Multitasking, Negotiation Skills, Organizational Skills, Product Costing, Product Development, Product Documentation, Product Lifecycle, Product Requirements Document (PRD), Product Reviews, Production Support, Quality Assurance Methodology, Quality System Requirements (QSR), Regulations, Requirements Management, Requirements Management Software, Research & Development (R&D), Risk Management, Safety/Work Safety, Software Design, Software Engineering, System Test, Team Player, Technical Marketing, Technical Support, Technical Writing, Technical/Engineering Design, Testing, Usability Engineering, Validation Plan, Validation Testing

LOCATION

Boulder, CO

POSTED

30+ days ago

Must Have: Bachelors degree (minimum) in Engineering or Scientific discipline and 0-2 years of technical engineering experience Detail-oriented with strong commitment to quality and to the workplace. Excellent analytical, organizational, and communication skills. Strong ability to work with multidisciplinary and global teams. High tolerance for change, and ability to multi-task continuously. Nice to Have: Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans, and/or validation reports. Experience in the medical device industry. Experience supporting EU-MDR and State of the Art Remediation Initiatives. JOB DESCRIPTION Top 3 things you are looking for in a candidates experience (please be specific): Experience working in an engineering discipline (preferably medical) Good communication and ability to work within a large cross-functional team Detail oriented with excellent organizational skills Education Required: B.S. in an Engineering Discipline (Mechanical or Electrical preferred) Years Experience Required: 0-4 in an Engineering role Will the contractor be working 40 hours a week? If not, weekly estimate? Any OT and if so how much? 40hrs/week Does this position require the candidate to be onsite or remote? Onsite A Day in the Life The Associate R&D Engineer will work as part of a team, providing technical support on Sustaining Project Initiatives, ensuring medical devices are designed with the utmost regards to safety, reliability and quality. The Associate R&D Engineer will be responsible for creating and updating technical documents that make up the Design History File, conducting IEC and Applicable Standards Assessments, Developing and Executing Verification Test Protocols. Areas of expertise should include: practical application of engineering design methods through all stages of the product development life cycle, with specific focus on developing design requirements, establishing test methodology, and applying risk management principles associated with the design and maintenance of regulated Medical Devices. Surgical Innovations seeks candidates who will meet our customers expectations by striving without reserve for the greatest possible reliability and quality in our products, processes, and systems by being accountable, having a voice, and taking action. They must have an entrepreneurial spirit, a can do attitude, be comfortable dealing with ambiguity, and to be confident about being able to apply business acumen to help make pragmatic trade-off decisions between time-to-market, product costs, product reliability, product features, and budget. Responsibilities Include: Provides technical support on New Product Development and Sustaining Project Initiatives by developing solutions for problems somewhat complex in nature and/or of moderate organizational impact with a high level of accountability, and moderate level of authority. Responsible for assuring all assigned work activities are completed in accordance with all applicable regulatory requirements including FDA Quality System Regulations 21CFR Part 820, Medical Device Regulation(MDR) (EU) 2017/745, Canada Medical Devices Regulations (CMDR) (SOR/98-282) and internal *** procedures Applies knowledge of IEC 60601-1 and 60601-2-2 Medical Electrical Equipment and collateral standards, and IEC 62366 Usability to project initiatives Serves as a design representative on one or more project teams engaged in New Product Development or Sustaining project initiatives, conducting literature and material reviews, performing National & International standards assessments, and generating and executing verification test protocols Reviews and approves product documentation, drawings, process and design verification/validation technical reports Interfacing with all project team members including engineering (mechanical, electrical, software, systems, and test), quality, regulatory, marketing, technical communications, end users, technical support, production and suppliers Must Have: Minimum Qualifications Bachelors degree (minimum) in Engineering or Scientific discipline and 0-4 years of technical engineering experience; or Masters degree in Engineering or Scientific discipline Detail-oriented with strong commitment to quality and to the workplace. Excellent analytical, organizational, and communication skills. Strong ability to work with multidisciplinary and global teams. High tolerance for change, ability to multi-task continuously. Strong negotiation, conflict management, and influence management skills. Nice to Have Experience with Requirements Management Software such as Polarion or DOORS Experience in the medical device industry. Experience generating technical documentation such as product requirements, specifications, engineering reports, test plans & procedures, validation plans, and/or validation reports. Experience supporting EU-MDR and State of the Art Remediation Initiatives.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

Assoc R-D Engineer - Exempt

LanceSoft Inc

Boulder, CO

About the Company

LanceSoft Inc

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