POSITION DESCRIPTION:

Access Vascular is seeking an individual who will work independently and in matrixed teams using engineering expertise to plan, coordinate and execute R&D projects and initiatives to support the development of new products and expansion of existing products.

Experience expected for successful applicants includes 10+ years’ experience in the field of implantable medical device development under design control.  This individual will require some supervision; yet will work independently and with others as a team contributor and/or leader.  Good communication skills are needed to understand and manage product needs as conveyed from internal and external sources.  This individual may also provide direction and mentorship to junior team members, and excellent communication skills with customers, fellow technical staff, and management is required.

This position is on-site at Access Vascular’s Billerica, MA facility and reports into the Manager of Product Development.

POSITION RESPONSIBILITIES:

• Candidate will participate in new product development, line extension, and sustaining projects while developing and processing Access Vascular’s novel material into various commercial products.
• Establish, execute, and report on the design control deliverables taking concepts through Design Verification, Design Transfer and into commercialization. Includes fabrication and testing of prototype devices and communication with project teams.
• Translate market level requirements into product level design specifications.
• Must plan, design and execute studies utilizing statistically based and DFMA approaches to characterize data and products. Clear and concise reports to be generated from datasets.
• Execute V&V activities on schedule and at required cost, quality, and performance levels.
• Coordinate prototype build plans to evaluate design concepts through physical lab testing. Efficiently leverage prior development work where applicable, and apply critical thinking to newly defined testing methods and requirements.
• Collaboration with co-located process development and manufacturing teams to ensure cross-functional support is considered during product development efforts
• Must apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments. Must make data-based decisions on engineering problems and suggest future iterations/testing.  Must keep clear record of past testing, results and learnings.
• Must be able to work in a project-focused team. Expected to partner with the Marketing, Operations, Quality and Regulatory Affairs departments during all phases of product development.
• Must ensure their work is conducted in accordance with current cGDP and Medical Device requirements. Maintain compliance with all appropriate SOPs for product development work and data recording. Use and maintain lab/manufacturing equipment in accordance with established SOPs and Work Instructions.
• Conduct design verification activities, and define product performance characteristics. Establishes test protocols specified by customer input, national and international standards, and regulatory requirements.
• Provide regular updates to various internal audiences.
• This individual may supervise engineers, engineering support/technicians and/or co-ops.
• This position may be responsible for interacting with outside contractors.
• Position will require travel up to 10%.

EDUCATION REQUIRED: 

Specific minimum educational requirement and or equivalent experience/education mix

• A minimum of a Bachelor’s degree in Mechanical, Chemical, Plastic/Materials, Biomedical Engineering, or a related discipline is required.
• Master’s degree is preferred.

YEARS OF EXPERIENCE:  

• With a BS, 7+ years of experience in a medical device company, with demonstrated experience in design control. 10+ years of experience a plus.
• With a MS, 5+ years of experience in a medical device company, with demonstrated experience in design control.

SPECIALIZED KNOWLEDGE REQUIRED:  

• In-depth understanding of quality systems and risk management activities.
• Early phase Class II or Class III medical device design experience.
• Working knowledge of a cleanroom environment.
• Design proficiency as it relates to medical devices.
• Experience in the field of implantable medical device development under design control.
• Demonstrated ability to adapt and overcome project challenges in a fast-paced constantly evolving environment.
• Familiarity with FDA requirements associated with the development of medical devices including Design Controls and the technical support required for regulatory submissions.
• CAD (SolidWorks), drawings, and GD&T experience.
• Work under minimal supervision.
• Excellent time management, organizational, and prioritization skills to successfully complete a wide variety of complex job duties and responsibilities in a timely manner.
• Work in a team environment.
• Hands-on work/understanding of extrusion theory and practice is a plus.
• Formulation chemistry (polymer and/or hydrogel) and product development experience are a plus.

PHYSICAL JOB REQUIREMENTS:

Physical capabilities to perform the job:

• Must be able to lift 30 lbs.
• Must have a valid driver’s license.
• Candidate must demonstrate a high measure of cleanliness.
• While performing the duties of this job, the employee is regularly required to stand, sit, walk, talk, hear and reach with hands and arms. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls.
• Specific vision abilities required by this job include normal vision.

 

WORK ENVIRONMENT:

• A willingness to work in a laboratory environment is required.
• Excellent mechanical skills, including the ability to manipulate common hand tools, is required.
• Ability to read, write and communicate in English

About Access Vascular

Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .