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Product Development Engineer

2 months ago

Brea, United States LanceSoft Full time

Description:

Max bill rate $70/hr
3 days/week onsite

Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems. Demonstrates working knowledge of product design and development. Demonstrates working knowledge of design control process. Tests, analyzes and solves technical problems with moderate guidance. Applies basic statistical techniques and utilizes design of experiments with moderate guidance. Translates customer needs into design inputs; verifies design output meets design input. Works with moderate guidance. Translates requirements into basic designs under the guidance of others. Creates and tests prototypes. Maps the intellectual property landscape. Has developed knowledge and skills in own job family; still acquiring / expanding fundamental knowledge and higher-level skills. Applies knowledge and skills to a variety of standard activities. Works with moderate guidance in own area of knowledge.

CLIENT is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Project Responsibilities
While maintaining a Customer Focus, responsibilities include (but are not limited to): Strategy development and Execution for Qualification of Medical Devices inclusive of Design Verification, Design Validation and Design Transfer activities.
•The R&D Senior Engineer will impact healthcare business groups by driving commercialization of new products and design changes for current products through development, qualification and launch phases.
•The R&D Senior Engineer contributes to building organizational effectiveness through creating, leveraging and sharing best practices; seeking and providing training; driving technical and workflow innovation.

This requires:
•Creating, editing, and interpreting technical drawings
•Design Verification Strategy Development
•Functional Device Testing
•Testing by Analysis
•Design Validation Strategy Development
•End User Validation Testing
•Technical writing (protocols, reports, work instructions, presentations, etc.) and effective verbal communication
•Expert application of engineering principles for design / analysis
•Statistical analysis and sample plan development
Innovation
•Identifies external technologies
•Identifies critical strengths and weaknesses
•Nurtures IDR's (Invention Disclosure Records) from infancy
•Continuous Learning
•Participates in external activities to enhance the brand recognition of CLIENT by writing papers and generating IP (Intellectual Property)
Leadership
The R&D Senior Engineer will demonstrate and cultivate:
Accountability: strong and clear accountability for the successful and timely achievement of goals.
Ability to assess project / program needs, engage and mentor team members, formulate strategy, build support, and execute; proactively identify and mitigate risks.
Proposes strategies to build functional capability
Effective Communication:
•Hold and encourage frequent formal and informal communication within the team and the rest of the organization to ensure dissemination of important information.
•Final recommendations to decision making committees
•Resolves conflicts within team by facilitating communication
Organizational Influence:
•Strong interpersonal influence and persuasion skills; situational awareness; ability to persuade or be persuaded based on evidence with or without authority.
Inclusive work environment.
•Promote and leverage diversity to achieve best outcomes.
Decisiveness Despite Ambiguity:
•Developing agility and action orientated when facing change and uncertainty.
•Autonomously drives projects/deliverables.
Required Qualifications
•Bachelor's Degree in Mechanical or Biomedical Engineering with a min.of 6+ years of experience in medical device or other regulated industry OR Advanced Degree in Mechanical or Biomedical Engineering.
•Track record of technical problem solving and effective product development.
•Design controls expertise for Medical or regulated industry experience.
•Design Verification experience, (Protocol Generation, Report Writing, Testing Strategies)
•Proficient in statistical methods / tools
•Proficient in solid mechanics / mechanics of materials
•Familiarity with traditional and modern fabrication techniques
•Knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO14971 and ISO 80369 and collateral standards.
Preferred Qualifications and Knowledge:
•Graduate degree (MS or Phd) in Mechanical Engineering, Biomedical Engineering or similar
•8+ years of post-educational experience in Medical Device
•Sought as an SME (Subject Matter Expert) in one or more areas expertise
For certain roles with CLIENT, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with CLIENT's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.