Process Development Engineer, Adona Medical Apply
Adona Medical, a Shifamed Portfolio Company, is focused on innovating interventional approaches for heart failure, a complex and progressive condition. Heart failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally. To learn more about Adona Medical, please visit https://www.adonamed.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
The process development engineer contributes to medical device product design, development, manufacturing, and testing in accordance with the companys Quality System. Employee works in conformance with Company Standard Operating Procedures (SOPs).
Responsibilities, Skills & Hands-On Experience
- Develop, optimize, verify, and validate processes through bench, in-vitro, and in-vivo testing.
- Effectively document work throughout the development process inclusive of lab notebooks, component specifications, design reviews, Manufacturing Process Instructions (MPIs), QPIs, equipment qualifications, and process validation.
- Develop new manufacturing processes as needed, refine the process (through DOE and other methodologies) and implement the process into the production setting.
- Participates in vendor qualification and vendor audits, as necessary. Conducts internal audits, as assigned.
- Develop manufacturing processes by applying engineering knowledge and product design, fabrication, assembly, tooling, and materials.
- Perform process optimization and manufacturing scale-up as needed through developing and implementing ergonomic improvements to the process.
- Improve manufacturing efficiency as needed through planning and evaluation of workflow, space requirements and equipment layout.
- Research, develop, modify, and test manufacturing methods and equipment; perform IQ/OQ/PQ validations and gauge R&R.
- Provide training to associates, technicians and assemblers; assisting other technical associates as needed.
- Participate in risk management activities as needed.
- Utilize required Quality System procedures; adhere to the Quality Policy and quality system requirements, including maintaining accurate documentation.
- Support company goals and objectives, policies and procedures, and regulatory requirements (FDA regulations, ISO 13485, MDD, etc.).
Education & Work Experience
- B.S. in Mechanical, Biomedical Engineering preferred or equivalent industry experience (minimum of 7 years).
- Experience developing and executing process and/or equipment validations preferred.
- Must be proficient in SolidWorks.
- Understanding and exposure to principles of fixture design strongly preferred.
- Excellent communication skills: ability to work independently or in project team setting.
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.
