Osprey Medical, Inc. specializes in the commercialization of proprietary technologies designed to protect CKD patients’ kidneys from the harmful effects of dye. Our proprietary technologies reduce the amount of contrast (dye) used during heart catheterization procedures without compromising X-ray image quality for the physician.
• Our Mission is to improve outcomes in patients with Chronic Kidney Disease by reducing contrast induced Acute Kidney Injury (AKI) and lowering hospital costs.
• Our Vision is to make heart imaging procedures safer for patients with poor kidney function.
We are looking for a Manufacturing & Process Development Engineer to join our regulatory team. This person will be responsible for developing, implementing, and continuously improving all manufacturing processes for both electrical and mechanical manufacturing processes. Candidate must have a strong electro/mechanical background. Establish best in class manufacturing processes using proven methods such a Lean Mfg. and 5S. Two primary areas of focus will be current products in production and new product development.
We are looking for a self- motivated candidate with the ability to manage timelines and be a part of a creative and collaborative team. They should be a self-starter who likes challenges requiring critical thinking, project management and has keen problem-solving skills. In this role, your work will include activities such as;
• Design and document all manufacturing processes for new products and existing products in production that are conducive to quality, are scalable, and efficient.
• Work closely with and train manufacturing operators.
• Represent manufacturing on critical new product development team projects.
• Identify and execute continuous improvement initiatives focused on quality, cost and delivery.
• Develop and implement tooling, fixturing and equipment.
• Oversee the equipment and tooling maintenance program.
• Identify the need, develop and conduct all process validations
• Troubleshoot problems in pre-production and production.
• Help define and lead efforts toward successful achievement of the department's goals.
• Engineering Degree- BSEE, BSME (with significant electrical experience).
• 3-5 years' experience with a medical device company.
• Experience with electromechanical instruments a must.
• Experience with single-use disposables made of plastic desired.
• Must be self-directed and driven toward being best in class.
• Proficient in establishing and conducting Process Validations.
• Quick to respond and excellent in solving complex technical problems.
• Experience working with electronics and software a must.
• Experience in developing processes that are scalable and efficient.
• Excellent interpersonal, organization, computer and project management skills.
• Excellent oral and writing skills to communicate technical information.
• Demonstrated sound judgment in reviewing technical data, protocols, and applying manufacturing principles.
We offer a competitive benefits package that includes:
• Long-Term Disability Coverage, Life Insurance, AD&D
• Health Savings and Flexible Spending Accounts
• 401k with company match
• PTO and Paid Holidays