Senior Product Development Engineer
SEEKING: A HUSTLER | A GRINDER | AN INNOVATOR | AN EXECUTION MACHINE
A “WHATEVER IT TAKES” SENIOR PRODUCT DEVELOPMENT ENGINEER
Why Avitus® Orthopaedics? We’re an exciting medical device company that has pioneered the Avitus® Bone Harvester; a product that is revolutionizing autografting for reconstructive orthopaedic surgeries. We are dedicated and committed to excellence, innovation, and solving unmet clinical needs to improve our universe. Our products will continue to be groundbreaking. We are a company that’s about hustle, grind, and taking relentless action to execute our goals. You have the opportunity to join us at an intersection of funding, commercial growth, and new product development. In addition to our current products on the market, you will have a critical role in designing, developing, and launching new game changing products! We’re a lean Company without bureaucracy; often decisions are made over coffee.
Who are we looking for? You enjoy constructing visions in your head and building them into life. You hate to fly under the radar; you want to be referred to as an execution machine. You want to tinker. You want to think. You must be a no BS kind of person; if you don’t know something, you’ll let us know and we’ll figure it out together. The ethos to who you are as an individual encompasses integrity, intensity, and intellectual honesty. You’re someone that can literally do the job of 10 people not because you work longer, but because you work smarter. You’re not a 9-to-5 person; you’re a get-it-done person. You love the grind. You have ideas, you have suggestions, and you want them to be taken into serious consideration and will trust the right suggestions will be put into motion at their respective right times. Quit is not in your vernacular. You must be a positive mindset individual who sees problems and challenges as opportunities of growth and ascension. Your follow-up game is relentless. You are incredibly proactive. Your solutions are win-win.
What are you going to do? You will be tasked with developing game changing solutions to meet the unmet needs of our users. You are going to systematically build concepts, experiments, and tests to answer design-guiding questions to develop proofs of concept for various solutions that our surgeons and patients need. You will then take these proofs of concept and get them to market through our product development process following design controls. You will be assigned various design responsibilities related to our existing innovative orthopaedic products. You’re going to be called upon to have to wear multiple hats at times to support our dynamic environment. You’re going to help us continue evolving our lean, creative, and fun culture. You’re going to be an excellent communicator. You will implement a whatever-it-takes mentality to balance costs while engineering significant progress towards our design goals.
You will march projects down the design control pathway into finished commercial products and orchestrate the supporting cast to success. You will develop new intellectual property.
As a Senior Product Development Engineer, you will be tasked with turning innovative ideas into medical device reality. You will take engineering notebook sketches and bring them to commercial life while navigating existing intellectual property landscapes.
You will at times have to use some elbow grease and execute tasks to get other operations done. People will depend on you. If duty calls, you may need to be a sales rep, a fulfillment specialist, a janitor, a market researcher, or a business development associate for a day.
As a Senior level player, you will be a mentor to those around you.
You will report directly to the VP of Operations.
You will have direct support from the Founders of the Company.
Essential Responsibilities and Duties:
- Design and development of medical devices from ideation to production release
- Develop the right design questions to then design the right testing & experiment setups to answer design-guiding questions
- Design, develop, and fabricate prototypes to be used for design evaluations during new product development process; manage fabrication of those prototypes in-house and through suppliers
- Maximize execution on all actions that lead to proof-of-concept
- Develop/document testing protocols and assist in the testing process for new and existing products
- Take proof of concept and lead DHF efforts through the design control process to get to production release of the finished product
- Develop and design minimum viable product balancing must-haves vs. nice-to-haves
- Analyze and comprehend test results to formulate suggested next steps to the team
- Interface with suppliers, contractors, testing houses, etc., forming collaborative relationships
- Work directly with Sales/Marketing/Clinicians to transform clinical inputs into design specifications
- Observe surgery (live, cadaver, or video) and formulate physician comments/ideas into meaningful design solutions
- Maintain efficient but thorough documentation with attention to detail
- Assist on patent application process
- Assist with other ongoing development projects and team initiatives when needed while balancing own workload
- Provide technical support and documentation support as needed for Regulatory and Quality
- Proactively bring management into decisions and meetings to discuss and decide on actions
- Constantly find ways to improve design processes, implement efficiencies, and optimize workflow
- Contribute to and support quality control procedures as needed
- Support ongoing operations and firefighting as needed
Essential Qualifications and Skills:
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related discipline plus 5+ years of medical device product design experience -OR- 8+ years of professional medical device product engineering and design experience
- 3D CAD, Solidworks (expert)
- Demonstrable experience with product development from black-box concept to testing to production release.
- Strong in geometric dimensioning and tolerancing (GD&T)
- Experience with design optimization and simulation (ANSYS, FEA working skills preferred)
- Strong understanding of prototype fabrication techniques (e.g., machining, 3d printing, laser cutting, etc.) and their design tradeoffs
- Microsoft Office Suite proficiency
- Experience developing disposables and implants
- Strong working knowledge of manufacturing techniques/methods
- Extensive knowledge of orthopaedics preferred
- Previous orthopaedic medical device and design experience preferred
- Very strong analytical skills and creative problem-solving skills
- A straight-shooting, open communicator
- Ability to record actions that are verbally communicated and clarify as needed prior to execution
- Ability to balance business and technical risks while being compliant with internal and external regulatory/quality requirements
- Ability to collate information and knowledge to find an answer when coming across an unknown
- Ability to define problems, establish facts, and utilize critical and logical reasoning to draw valid, viable conclusions
- Ability to actively acquire knowledge of new and advanced manufacturing/design technologies to help Avitus® continue improvement
- Computational fluid modeling abilities a plus
- Deploying de-risking techniques to “get it right” the first time when and where appropriate
- Demonstrable bias for action, must be a DOER
- Mentorship and management skills of one or more engineers and other team members
- Strategic thinker: excellent team collaborator with attention to detail balanced with a long-term vision
The team member will be required to have close visual acuity to perform activities such as inspecting small parts and viewing computer terminals and drawings. The team member may be required to lift up to 35 lbs. by themselves. The team member may need to stand in an operating room with 10lb lead vest for long periods at a time.
Expected Work Hours:
This is a full-time position with typical start-up business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager. Occasional remote work may be allowed as needed.
Potential for some overnight travel. May require up to 2 hour drives to suppliers.
Must be legally authorized to work In the US on a full-time basis.
Employment visa sponsorship not available.