Instylla Inc Looking for R&D Engineer at Bedford, MA Full Time

Position Summary/Role and Responsibilities:

The Research and Development (R&D) Engineer will develop new technology, products, test methods, processes, and/or equipment in support of the commercialization of novel embolization and hemostasis technologies. Independently, or as a member of a team, executes plans for challenging projects. Compiles and analyzes data to establish technical specifications for designing or modifying products, processes, and materials.

· Assist in translating customer needs into product requirements and design specifications.

· Performs activities related to product verification and device validation.

· Execute engineering work in the following areas: product design and development, test method creation and validation, component and device specification generation, process analysis and documentation, pre-clinical research, and design control documentation.

· Interface with Quality to ensure that products are designed for patient safety in terms of FMEA, hazard analysis, and Quality System compliance.

· Conduct experimentation, summary, analysis, drawing of conclusions, and making of robust recommendations.

· Effectively communicate, both oral and written, technical information to broad audience including project team and stakeholders.

· Assist with obtaining feedback on concepts and performance of devices under development from physicians and key opinion leaders.

· Work collaboratively across functions to define and execute projects.

Supervisory Responsibilities:

• May train and/or provide work direction to other entry-level engineers or technicians.

Qualifications and Education Requirements

• BS Degree in Mechanical/Biomedical Engineering with a minimum of 3-5 years experience within the medical device industry
• General knowledge of medical device industry and design control guidelines.
• Has served as Lead Engineer/Tech Lead on at least one program.

Knowledge/Skills:

• Solid technical background in engineering discipline.
• Demonstrate knowledge of medical device product development process.
• Hands-on experience in the testing, prototyping, building, modeling, etc. of disposable medical devices.
• Excellent interpersonal skills and ability to motivate others.
• Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
• Excellent organizational skills and attention to detail.
• Quality orientation.
• Willingness to learn.

Preferred Skills

• Knowledge of implantables, vascular or interventional oncology devices.
• Knowledge of vascular catheter delivery systems.
• Knowledge of device manufacturing processes (extrusion, molding, assembly, machining)
• Working knowledge of Solidworks or similar computer aided design and engineering software.

Working Conditions:

· Office environment.

· Mechanical testing lab environment.

· Ability to drive to local sites and travel long distances, and stand with lead protection for 2+hours to support preclinical procedures.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Parental leave
• Retirement plan

Schedule:

• Monday to Friday

Supplemental Pay:

• Bonus pay

COVID-19 considerations:
Instylla has a COVID-19 vaccination mandate.

Education:

• Bachelor’s (Required)

Experience:

• medical device engineering: 3 years (Preferred)

Work Location: One location