Job Description
Job Description
About Scientia Vascular:
Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.
Position Summary:
This position will work closely with the Research and Development and Manufacturing Engineering teams to bridge the development of new products from R&D into production. As a Transfer Engineer you will develop new manufacturing processes, drive product transfers, optimize manufacturing processes, and scale manufacturing line capacity all while ensuring quality, safety, and cost targets are met.
Primary Responsibilities:
- Collaborate cross-functionally to facilitate transition of new products from early ideation through to fully implemented manufacturing processes
- Work cooperatively with research and development, quality, operations, regulatory, and marketing to ensure project success
- Provide expertise in specification setting, equipment procurement, build documentation, work instructions, process validation, and personnel training on manufacturing equipment/processes
- Completes process validation activities for manufacturing processes. Ensuring compliance with applicable FDA and international regulatory standards
- Performs troubleshooting on new products/processes related to design, material, equipment, and process. Must be comfortable working in a hands-on manufacturing environment
- Designs, performs, and analyzes engineering tests and experiments
- Designs, procures, and fabricates tooling and fixtures
- Contributes to intellectual property position of company by inventing concepts and designs for new products/processes and submitting idea disclosures
- May train and/or provide work direction to technicians
- Additional duties and responsibilities as assigned
Requirements:
- Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field
- Ability to interact professionally and in a collaborative manner across all organizational levels
- Minimum of 3 years experience working in a regulated industry, medical device preferred
- Understanding of cGMP and Medical Device manufacturing regulations preferred
- Solid problem-solving, organization, and analytical critical thinking skills with an emphasis on statistical data analysis.
- Ability to lead a project from early ideation through to full completion
- Strong written and oral communication skills
- Proficient in Excel and Word
Key benefits we provide:
- Medical, Dental, Vision insurance
- Generous Paid Time Off (PTO)
- Paid Parental Leave
- Paid Holidays
- 401k Plan (with a generous employer match)
- Life Insurance (company paid)
- Short-Term & Long-Term Disability Insurance (company paid)
- Subscription to Calm.com
- Employee Assistance Program
- An environment of belonging where everyone can thrive
Commitment to Equal Opportunity:
The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, sexual orientation, national origin, genetics, disability, age, or veteran status, or any other non-merit based or legally protected grounds.
Visit our website and learn more about us at www.scientiavascular.com.