Engineer - Verification and Validation RD (Mid Level)
Location: 100% onsite - Marlborough MA 01752
1 year initial contract (possible extension)
Hourly Pay Rate: $51-55/hr (medical benefits available at a cost)
What you’ll do:
• Lead and execute Verification and Validation (V&V) activities for disposable kit development.
• Define test plans, methodology, test equipment, and resources to support design Verification and Validation activities.
• Set-up design of experiments (DOE) and/or review plan and results to support product evaluation and process development.
• Establish acceptance criteria and sampling plans through statistical analysis or qualitative and quantitative testing.
• Develop best practice guidelines for performing disposables kit Verification & Validation activities and champion standardization and harmonization within the R&D team.
• Perform and document technical root cause investigations in collaboration with R&D hardware, software, application, manufacturing, biology, and disposable kit system matter experts (SMEs).
• Support Risk Analysis activities within the R&D team and contribute to product Risk Management File (RMF).
• Advise R&D team members on execution of process validation (IQ/OQ/PQ) activities and metrology best practices.
• Support R&D supplier capability and quality audits.
• Mitigate project technical risks, resolve issues, deliver on-time, and establish strong communications with internal and external stakeholders.
• Assess product specifications and change control documentation for improving the manufacturing of new and existing devices.
• Support R&D team in developing supplier quality plans, supplier specifications and defining CTQ requirements.
Who you are:
• Bachelor’s degree or equivalent in related engineering or scientific fields (mechanics, micro-mechanics, materials...). Long lasting experience (e.g. 6-10+ years) in designing, developing and manufacturing plastic disposable kit products for a regulated industry (e.g. medical device, class II and/or class III).
• Experience in design verification activities related to disposable kits for medical device application associated to manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding.
• Expertise in test method validation (e.g. DOE, OQ, Gage R&R, ), mechanical testing (e.g. pull/peel test, burst test, leak test, dye test, bubble test,...), in packaging design, transportation conditions simulation (e.g. ISTA) and stability study (e.g. pre-conditioning, aging test,...).
• Familiar with disposable product manufacturing processes such as injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding and ISO class 7 & 8 cleanroom operations.
• Knowledge of materials biocompatibility (ISO 10993 and USP 88), leachable & extractable (E&L) evaluations and sterilization techniques is a plus.
• Experience with medical device risk management and risk analysis (ISO 14971).
• Knowledge of statistical data analysis, methods, and tools (Minitab or equivalent).
• Experience with test method validation (TMV), Gage R&R and process capability analysis.
Pharmaceutical company looking to hire a Clinical Data Manager or a Senior CDM Salary - $125K - 140K depending upon experience level. 3-5 years of experience Knows Data Management well SAE reconciliation Create Data Management Plans. DMP Data transfer...
...Consider the possibilities of joining a Great Place to Work!Provides administrative and clerical support to a standalone funeral home, cemetery, crematory or a combination of these facilities. Guides families through available options for services during the time period...
...Access hospitals with Level 4 Trauma designations and seven medical clinics. Nestled among high mountain prairies and rivers, we offer a... ...Description This is a full-time on-site role for a Registered Nurse. The Registered Nurse will be responsible for providing direct...
...Emilia-inspired infant/toddler program for next year. This is a hands-on, supportive role ideal for someone passionate about early childhood education and eager to grow within a reflective, team-oriented environment. Core Responsibilities: Support Daily Communication...
Required Qualification: Bachelors degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education. At least 2 years of Information Technology experience...