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SoloPoint Solutions, Inc.
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https://www.solopointsolutions.com
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USD
160000
YEAR
true
Sr. Principal Mechanical Engineer
2024-10-22
2024-12-25
Employment Type:
Direct
Category: Mechanical Engineer
Job Number: 10216
Pay Rate: $160,000
Job Description
Qualifications:
Responsibilities:
- BS/MSME 10 years’ experience in medical device development
- Demonstrated experience taking a Class II or Class III medical device through development, DVT, and regulatory approval (510K, PMA, FDA, CE approval)
- Experience building and leading a multi-disciplinary team through product development, validation, clinal trials, clinical release
- Hands-on in mechanical design, CAD usage (SWx), test development, prototyping
- Experience managing fabrication vendors, suppliers, test and clinical trials organizations
- Excellent verbal and written communication skills
- Excellent interpersonal and presentation skills
- Work in the office/lab 3-4 days/week
Responsibilities:
- Leading program management, process engineering, design engineering, document control, purchasing, quality assurance engineering, and quality inspectors
- Setting company technical vision and leading the company's technological development
- Developing strategic plans and setting timelines for evaluation, development, and deployment of devices
- Identifying opportunities for technological improvements
- Collaborating with department heads, regulatory, clinical, marketing, production, and operations as an advisor of all technologies involved with the company
- Ensuring technology standards and best practices are met
- Ensuring that technological resources meet the company's short and long-term needs.
- Outline the goals for research and development and spearhead the execution.
- Creating timelines for the development and deployment of all technological services.
- Monitoring quality system and making recommendations that align with business goals
- Supervising quality assurance processes, integration, and system tests
- Coordinate and supervise with medical contractors
- Mentoring team members
- Sharing technological visions, opportunities, and risks company-wide
- Studying current and new industry trends, technologies, and device development
- Studying information processing systems to evaluate the effectiveness and make recommendations for improvement.
- Representing the company at conferences and networking events
- Ensuring the company's technological processes and service comply with all requirements, laws, and regulations