As a design engineer, you will work with a small and agile team of experienced hardware and software engineers to develop new product applications and support existing products. In doing so, you’ll work closely with customers and clinical trial partners, as well as the Accure commercial team, to better understand clinical applications, resolve issues, and provide support.
This is a roll-up-your-sleeves, do-what-it-takes job. It’s exciting and rewarding work, and a zest for developing cutting edge solutions that help people is a key to success.
Specific duties and responsibilities include, but are not limited to:
· Lead product development efforts (project specific) through all phases of design (e.g. feasibility through transfer to manufacturing).
· Create and manage solid models, assemblies and drawings using SolidWorks and SolidWorks Vault.
· Manage and report on project timeline/completion of tasks to ensure timely completion as projected.
· Establish and implement validation requirements for products, test methods and manufacturing processes
· Write design and process validation protocols and reports.
· Write Hazard/Risk Analysis (per ISO14971) and FMEAs (Design and Use)
· Create Item Masters and Bills of Materials. Support their entry into ERP system
· Lead project document control efforts in the entering of documents into Quality System Vault and maintaining solid models not resident in the QS Vault (e.g. SolidWorks Vault).
· Create and maintain FDA compliant Design History Files (DHF).
· Support quality system compliance with FDA QSR and ISO 13485, and regulatory submissions.
· Develop, commercialize, and support innovative medical laser products
· Provide expertise and guidance on industry best practices and regulatory requirements
· Work with commercial and field service teams to track and resolve issues
· Analyze technical issues with devices to find root cause and develop solutions
· Assist in the research & development of new device technologies and capabilities
· Perform analysis and hands-on laboratory work
· Work closely with principal investigators on clinical trials and application development
· Travel to clinics, conferences, etc., as needed
· BS in mechanical or relevant engineering discipline – biomedical engineering a big plus
· Strong background in medical device engineering
· 4 years of engineering experience in design and development of complex, medical electrical devices
· Working knowledge of quality systems regulations i.e., FDA QSR, ISO 13485, is required
· High degree of initiative and self-motivation with a strong sense of accountability
· Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
· Excellent organizational skills and attention to detail
· Strong communication skills, both oral and written
· Ability to prioritize, multi-task and adapt to change
· Ability to work effectively in a team environment and build strong working relationships
· Ability to interact professionally and positively with external partners and customers
· Comfortable working in clinical environments (physician offices, hospitals)
· Willingness to work in the company office full time*
· Willingness to travel up to 15% of the time annually
*Working remotely is allowed if approved by a manager and only as an exception
Specific Skills Required
· Strong proficiency with solid modeling – SolidWorks a plus
· Good hands-on skills – adept at building prototypes, setting up & running tests
· Design for manufacturing experience – CNC machining, 3D printing, injection molding
$140,000 - $190,000 per year