Medical Device Product Development Engineer
Medical Device Product Development Engineer
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Together, we can provide natural bone to where more bone is needed most.
At Lenoss Medical we bring together the world’s best talent to realize our vision of treating spinal fractures and providing natural bone where more bone is needed most. Together, we work passionately to develop and deliver easy-to-use, safe, and efficient solutions to support bone healing.
We are in the process of building a highly motivated team of professionals driven to dramatically improve spinal fracture care by offering a first of its kind physiological bone healing solution. Our passion to change the stale and risky standard of care and improve the outcomes for the patients in need drives us with everything we do. We believe in ingenuity lies in simplicity and we pursue innovations which will lead to positive impact for patients and continued success of our business and shareholders.
As an integral part of our team, the Product Development Engineer at Lenoss Medical is responsible for working professionally and efficiently within our growing small business and holds the responsibility for a broad range of tasks. The tasks include the design and development of state-of-the-art medical devices in compliance with FDA quality regulations, performing design control and risk management projects, execute effective project management for multiple projects and support general business operations. General business operations tasks can vary from shipping a brochure to a customer to tasks related to support the Board of Directors or Investors and everything in between.
If you want to be part of realizing our important mission, building a motivated, collaborative and strong team and are comfortable working for a dynamic, high potential medical device business, we want to hear from you!
Primary Accountabilities
* Become an integral, professional, collaborative and effective team member
* Accountable for working cross-functionally with team members from sales, marketing, operations, regulatory, clinical and outside parties and vendors.
* Accountable for collaboratively establishing user requirements, design and develop safe and effective medical devices and human cell and tissue products (HCT/P’s)
* Quality Engineering
* Accountable for performing quality management system tasks such as design controls, risk management projects and post market product surveillance items
* Accountable for adhering to FDA regulations and compliance
* Project Management and Business Operations
* Accountable for diligent and effective project management for assigned projects and tasks
* Accountable for completing business operations tasks related to all aspects of the business
* Work closely with healthcare professionals to identify and address technical issues and user needs and find simple, innovative solutions to improve patient care. Responsible to apply creative problem-solving skills to address technical challenges and finding practical solutions
* Collaborate with healthcare professionals, researchers, and other engineers to create medical devices that meet the specific needs of patients and healthcare providers. Through this collaborative approach ensures that the devices are not only technologically advanced but also simple, practical and user-friendly
* Responsible for testing and evaluating the performance of medical devices, ensuring that they comply with industry standards and regulations. Conduct rigorous tests to assess the reliability, durability, and safety of the devices. Employ meticulous attention to detail ensuring the devices perform optimally and do not pose any risks to patients
* Advance multiple projects by employing effective project management skills while assuring highest quality and on time deliveries
* Partners closely with senior executives and CEO to form a strong, mutually supportive, collaborative and effective business team.
Minimum Required Skills And Knowledge
* Possess a strong foundation in engineering principles, combined with a deep understanding of human anatomy, physiology, and medical terminology. Must have excellent analytical and problem-solving skills, as well as the ability to communicate effectively with diverse stakeholders, including healthcare professionals, regulatory authorities, board members and investors
* Ability to stay up to date with the latest advancements in medical technology and regulations. Skilled in engaging in continuous learning and professional development to ensure that ever-changing demands of the healthcare industry are met
* Medical device design and development skills
* Computer aided parametric 3D modeling design skills
* Computer aided parametric ISO 2D print (blueprint) generation skills
* US FDA medical device quality management system, device design controls, risk management, post market surveillance and CAPA knowledge
* Professional, effective and collaborative interpersonal skills
* Ability to perform a wide range of tasks, within and outside of core competencies
Preferred Skills, Knowledge And Experience
* Master’s degree in biomedical engineering
* 5 years of medical device design and development experience
* 5 years of US FDA Quality Management System experience
* Experience of working within a start-up or small business
* ISO experience
* GD&T experience
* Medical device manufacturing knowledge
Building a new business and changing the standard of care calls for big ideas.
We envision fracture care to be physiological, simple and safe. Achieving this vision takes dedication and commitment from all of us, every single day. We celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We empathize with all our stakeholders, physicians and patients, which allows us to innovate and advance patient care and clinical outcomes. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences and collaborative teamwork. At Lenoss Medical, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to create simple, safe, physiological fracture care for patients in need.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Information Technology
* Industries
Medical Device
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