Principal R&D Engineer - Valve, Tioga Cardiovascular

Tioga Cardiovascular, a Shifamed Portfolio Company, is developing a minimally invasive, transcatheter mitral valve replacement therapy that is both easier to use and implantable in a higher percentage of patients with mitral regurgitation. To learn more about Tioga Cardiovascular, please visit www.tiogacardiovascular.com.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

As a Principal R&D Engineer on the Tioga team, you will play a key role in the product's design and development, process development, and verification & validation testing to support the product's clinical use. We are currently looking for a data driven, hands-on engineer who is a collaborative team player to lead valve development. This position represents an exciting opportunity to join the Tioga team as it enters the clinical evaluation phase.

Responsibilities, Skills & Hands-On Experience

• Lead Valve design and testing with limited supervision, contribute to product specifications and risk analyses.

• Contribute to the company's intellectual property via invention disclosures.

• Executing ISO 5840 in vitro and bench testing.

• Perform Statistical analysis (DOE, Regression, ANOVA, Capability Analysis, GR&R).

• Work in cross-functional team to shepherd designs through concept freeze, V&V testing, and clinical evaluation.

• Prepare technical documentation, including design documents, manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions.

• Mentor junior team members.

• Proficient in CAD design and documentation software; SolidWorks preferred.

• Experience with Nitinol processing, laser cutting and shape setting.

• Experience in developing and validating test methods, designing test fixtures, and qualifying test equipment.

• Knowledgeable about medical device regulations and design controls requirements, experience working in a quality system.

• Candidate must have strong communication skills: must be able to explain your work to technical and non-technical stakeholders alike.

• Ability to travel.

Preferred Skills & Hands-On Experience

• Nitinol finite element analysis (FEA) experience, Abaqus preferred.

• Advanced degree in engineering, Mechanical Engineering preferred.

• 10+ years' work experience, in the medical device industry preferred.

• Biological tissue material property characterization, FEA tissue modelling a plus.

Education & Work Experience

• BS degree in Engineering, Mechanical Preferred
• 10+ years' work experience, in the medical device industry, cardiac implant or heart valve experience preferred.

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $90,000 to $180,000 + equity + benefits.

NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.