Job Description
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TalentBurst, an Inc 5000 company provided pay range
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Base pay range
$45.00/hr - $52.00/hr
Position: Quality Engineer // Engineer - Verification and Validation RD (Mid Level), Req#: 4749-1
Location: Marlborough, MA (100% Onsite)
Duration: 12+ Months Contract
Shift: Mon-Fri 8 to 5
Note:
No Relocation assistance will be provided by TalentBurst and or Client.
The top 3 must-haves in a quality candidate for this role.
- Design Controls Knowledge particularly Design V&V
- Statistical background
Education and Experience:
- Bachelors 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 applications associated with 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.
Job Responsibilities:
- Lead and execute Design 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 for Design Verification and Validation
- Develop best practice guidelines for performing disposables kit Design 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 the product Risk Management File (RMF).
- Mitigate project technical risks, resolve issues, deliver on time, and establish strong communications with internal and external stakeholders.
- Assist the R&D team in assessing existing user and product specifications and revising or drafting new ones
Seniority level
Seniority level
Mid-Senior level
Employment type
Job function
Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
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Job Tags
Contract work, Relocation, Shift work,