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Sr R&D Lab Technician
Sr R&D Lab TechnicianSunrise Systems • Marlborough, Massachusetts, United States
Sr R&D Lab Technician

Sr R&D Lab Technician

Sunrise Systems • Marlborough, Massachusetts, United States
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Job Title : Sr R&D Lab Technician

Duration : 12 months Contract on W2 (possible extension based on performance)

Location : Marlborough, MA

Position : Onsite

Shift : Mon-Fri 8 to 5

Job Description :

Top 3 must haves for this candidate.

  • Participate in the design and organization of experiments in conjunction with the Tech Lead and / or R&D Team members. Serve as a resource to R&D Team perform and help develop hands-on tests of new products in development. This could include developing tooling and fixtures. Record test data in accordance with cGxP.
  • Prepare samples for test and evaluation. Testing frameworks will include both development and verification / validation phase contribute to the generation of work instructions, tests protocols, and reports.
  • Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, and maintain documentation in accordance with established procedures and interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform with established practices.

Role

Essential Duties & Responsibilities || Percentage of Time

  • 1. Manufactures department's batches utilizing all and any necessary equipment during any shift.
  • Set-up, clean and operate manufacturing and R&D equipment.
  • Perform and communicate all activities of the Department's batc1) works with other technicians, engineers, planning and manufacturing. 35%
  • 2. Completes physical testing and stability evaluations of department's batches utilizing a wide variety of analytical equipment. 25%
  • 3. Preparation of technical documents, such as but not limited to, alternate API qualifications, incident investigations, inter-office correspondence and SOPs, Creates computer generated statistics and graphics for use in technical documents, reports and protocols. 5%
  • 4. Supporting documents and materials for department's batches and projects. For example; but not limited to lab paperwork, laboratory notebook, sample preparation, sample accountability and sampling equipment. 15%
  • 5. Completes inventory and transactions relative to Department's batches 5%
  • 6. Coordinates, samples and monitors Validation batches during any shift. 15% Percentages will vary based on business needs, headcount and workload. Remaining activities :
  • 7. Participates as member of departmental or facility teams.
  • 8. Assists in maintaining regulatory compliance and follows all GMPs.
  • 9. Lift / move up to 10lbs, frequently 25 lbs and occasionally 40 lbs.
  • 10. Follows safety policies and procedures, hazard matrix and gowning procedures.
  • 11. Assist quality and R&D when needed.
  • 12. Performs other tasks assigned or required by business needs.

    • Position Requirements

  • Education : High School diploma or GED.
  • Experience : High School diploma or GED Company-Related Knowledge : Strong working knowledge of manufacturing operations required. Strong working knowledge of cGMPs.
  • Functional Knowledge : Strong understanding of the function of process engineering and validation for the company.
  • Computer and math skills.
  • Ability to lead peers and junior technicians.
  • Ability to bring practical knowledge into technical decision-making.
  • Strong communication skills.
  • Works independently with minimal supervision once assignments or responsibilities are outlined and delegated.
  • Responsible for testing of current experimental, probational and special tools in simulated field conditions. Records test results and produces related reports.
  • Ensures safe operation and maintenance of machinery and test fixtures.
  • Ensures testing is conducted with proper safety precautions.
  • Assist in training department personnel.
  • Directs or assembles equipment according to engineering specifications.
  • Other duties as assigned. High school education or equivalent.
  • Minimum three year related experience.
  • Knowledge of all relevant testing equipment, material properties and machinery characteristics.
  • High School Diploma or equivalent. 5+ years test lab experience.

    • What you'll do

  • Participate in the design and organization of experiments in conjunction with the Tech Lead and / or R&D Team members. Serve as a resource to R&D Team.
  • Perform and help develop hands-on tests of new products in development. This could include developing tooling and fixtures. Record test data in accordance with cGxP.
  • Prepare samples for test and evaluation. Testing frameworks will include both development and verification / validation phase.
  • Collaborate with colleagues as necessary to gain access and training.
  • Contribute to the generation of work instructions, tests protocols, and reports.
  • Follow departmental work instructions, SOP's, OSHA safety regulations and cGxPs to perform assigned tasks.
  • Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, and maintain documentation in accordance with established procedures.
  • Interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform with established practices.
  • Interface with external groups as Client factories and suppliers to assure design transfer activities and to manage logistics for lab supply and samples.

    • Who you are

  • Associate Degree in Technology or Engineering or equivalent combination of education and work experience.
  • 8-10 years relevant work experience in medical device and / or life science industry (FDA 21CFR820, ISO13485).
  • Deep knowledge in medical device disposables (minimum Class II), with relevant experience in developing tests methods, writing test protocols, and verifying design specifications of new products.
  • Experience in manufacturing process development related to medical device or life science disposables an asset (IQ, OQ, PQ, Process FMEA).
  • Basic knowledge of mechanical design of fixtures (CAD Design - SolidWorks).
  • Familiarity with the mechanical testing of plastic parts and sub-assemblies (e.g., pull test, tensile / shear / compression test, integrity / leak testing (vacuum / pressure decay), burst test) and product reliability tests (e.g., ship testing, tear / wear / aging / stability tests).
  • Familiarity with assembly methods, especially those relevant to single-use biomedical products : mechanical fastening, heat sealing, UV-cure adhesive, part trimming / cutting, packaging, etc.
  • Familiarity with working in a cleanroom, laminar flow hood, or the like.
  • Background in metrology an asset.
  • Ability to work under cGxP guidelines.
  • Strong communication, interpersonal skills, and the ability to work in a team environment are required.
  • Demonstrate strong ethical behaviour.
  • Detail-oriented, and able to work independently as well as part of a team.
  • Possess good computer skills (Microsoft Office is required as Word, Excel, Minitab).
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