Job Description
Salary:
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:
The R&D Manager/Principal Engineer 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.
Job Duties and Responsibilities:
* The primary responsibilities for this role will be oversight 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.
* 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.
* 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.
* 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.
* 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.
Education Requirements:
* A minimum of a BS degree in Mechanical Engineering, BioMedical Engineering or Chemical Engineering (or an equivalent technical degree) is required.
* Masters degree in the above fields (or engineering management) is preferred.
Experience:
* With a BS, 7+ years of experience in medical device development required.
* With a MS, 5+ years of experience in medical device development required.
* Extensive knowledge and experience with the design control process of a medical device.
* Previous experience defining customer requirements, design inputs and outputs and successfully completed verification and validation activities.
* This individual will have many demonstrated successes of taking pilot processes to production-ready including documentation of Work Instructions and FORMs.
Knowledge & Skills:
* 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.
* Knowledge of sterilization validation, biocompatibility testing and both pre-clinical and clinical trials.
* Strong skillset within process development.
* 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 and verbal communication skills.
* High level of business acumen.
* Basic understanding of chemistry.
Other Requirements:
* The ability to conduct detailed visual and physical inspections and make observations of conforming and non-conforming materials.
* Long periods of time working at a computer.
* The ability to travel (including international) up to 10%.
* 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.
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