R&D Manager/Principal Engineer

About Us:

Pramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical devices from novel, proprietary hydrogel materials that improve patient outcomes while lowering the cost of therapy. We self-fund our projects through preclinical development and work with financial partners for clinical development and commercialization. Our portfolio of hydrogel technology positions us to be the leader in creating new hydrogel based medical devices to address unmet medical needs in a range of surgical interventions. We have launched over ten medical device companies based on this unique technology. These companies have generated over $4B in value, and have helped over 5 million patients worldwide achieve better outcomes.

Position Summary:

Pramand is seeking an individual who will work independently and in matrixed teams using product development expertise to plan, coordinate, and execute R&D projects and initiatives to support the development of new products and processes. The position requires extensive knowledge and experience with the design control process of a medical device. The candidate will have defined customer requirements, design inputs and outputs and successfully completed verification and validation activities. Additionally, this role requires working knowledge of sterilization validation, biocompatibility testing and both pre-clinical and clinical trials. The primary responsibilities for this role will be oversite of the technical portion of the project including scheduling/planning of all R&D work while interfacing and collaborating with all other functional groups. This role will define the technical direction for the project and ensure completion of deliverables to the larger project schedule. This individual will work under minimal supervision. Excellent communication skills are needed to understand and manage project/product needs and update status to internal and external customers. This individual will also manage and/or provide direction and mentorship to R&D team members. This position will report to Pramand’s Bedford, MA facility.

Principal Duties and Responsibilities:

• Individual will be responsible for all aspects of the project and its deliverables. This includes defining the long and short-term R&D and process development deliverables of the project as well as the mentorship of the engineers/chemists on the team.
• Candidate will demonstrate a strong skillset within process development. This individual will have many demonstrated successes of taking pilot processes to “production-ready” including documentation of Work Instructions and FORMs.
• Project management. This individual will be responsible for assembling, publishing and updating a schedule of all R&D and process development project deliverables while understanding how that fits into the larger company schedule.
• Mechanical aptitude. This individual will be responsible for the mechanical design of test fixtures and bench-top models for design verification and validation activities as well as fixturing or manufacturing aides for the manufacturing process. Additionally, they may be responsible for other aspects of the project including packaging design, biocompatibility (ISO 10993) and sterilization (ISO 11137).
• Establish, execute, and report on the process development deliverables of a novel process for a medical device. Create and document manufacturing and testing procedures and forms for recording process and testing data.
• A strong understanding and a working knowledge of 21 CFR 820 and ISO 13485. Experience with other worldwide regulatory agencies (CFDA, PMDA, etc.) a plus.
• Excellent written communication skills. This individual will own the technical documents (SOPs, Test Protocols and reports, FMEAs, etc.) for the project and will be responsible for the assembly of the R&D and process development deliverables for the DHF.
• Excellent oral communication skills. Effectively communicates and works cooperatively with others as part of a team.
• Leadership qualities. This position will manage engineers and/or co-ops and therefore the candidate must be able to develop, teach and provide mentorship to members of the R&D team. Additionally, the candidate must demonstrate a high level of business acumen.
• A basic understanding of chemistry.
• This position may require travel (including international) up to 10%.

Supervisory Responsibilities:

This position will manage engineers, scientists and/or co-ops and therefore the candidate must be able to develop, teach and provide mentorship to members of the R&D team.

Qualification Requirements:

Education

• A minimum of a BS degree in Mechanical Engineering, BioMedical Engineering or Chemical Engineering (or an equivalent technical degree) is required.
• Master’s degree in the above fields (or engineering management) is preferred.

Experience

• BS and 10+ years of experience in medical device development required
• MS and 5+ years of experience in medical device development preferred

Knowledge/Skill

• An understanding and working knowledge of design controls from FDA, ISO and MDD.
• An understanding and working knowledge of a medical device company’s quality system and its requirements.

Working Conditions:

• While performing the duties of this job, the employee is regularly required to stand, sit, walk and reach with hands and arms. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. While performing the duties of this job, the employee will conduct visual inspections and make visual observation of conforming and non-conforming materials.
• It is preferred that the candidate have a valid driver’s license as business travel is likely for this position
• It is preferred that the candidate be able to hold a company issued credit card as business travel and purchases are likely for this position
• A willingness to work in a laboratory environment is required
• A willingness to work in an Environmentally Controlled Area (ECA) is required
• A willingness to work with pre-clinical models is required