Accure Acne, Inc. Senior Medical Device Design Engineer Boulder, CO · Full time

Apply for Senior Medical Device Design Engineer

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

Qualifications

·      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 

Desired Skills

·      Design for manufacturing experience – CNC machining, 3D printing, injection molding