Design Verification Engineer

TalentBurst, an Inc 5000 company; Marlborough (MA); On-site; USD 61,992 - 71,635; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading engineering firm in Marlborough, MA is seeking a Quality Engineer with expertise in Design Verification and Validation for disposable medical products. The ideal candidate should have extensive experience in medical device design and will be responsible for leading critical quality assurance processes. This role offers a competitive hourly pay range of $45.00 to $52.00 and is fully onsite for a 12-month contract.

Qualifications

• 6-10+ years of experience in designing and developing medical devices.
• Experience in Design verification activities for disposable kits.
• Familiarity with medical device manufacturing processes.

Responsibilities

• Lead and execute Design Verification and Validation activities.
• Define test plans and methodology for Design Verification.
• Support Risk Analysis activities within the R&D team.

Skills

Design Controls Knowledge

Statistical background

Test method validation

Mechanical testing

Medical device risk management

Education

Bachelor’s degree in related engineering or scientific fields

Tools

Minitab or equivalent

Job description

2 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

TalentBurst, an Inc 5000 company provided pay range

This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

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:

• 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 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

• Employment type

  Contract

Job function

• Industries

  Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

Referrals increase your chances of interviewing at TalentBurst, an Inc 5000 company by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified about new Design Verification Engineer jobs in Marlborough, MA.

Boston, MA $80,000.00-$120,000.00 2 days ago

Hopkinton, MA $80,000.00-$100,000.00 2 weeks ago

Boston, MA $90,000.00-$130,000.00 4 days ago

Field Engineer - Electrical Construction

Waltham, MA $95,000.00-$105,000.00 3 days ago

Waltham, MA $140,000.00-$170,000.00 1 week ago

Boston, MA $90,000.00-$135,000.00 5 days ago

Medway, MA $88,000.00-$132,000.00 2 weeks ago

Greater Boston $110,000.00-$170,000.00 2 weeks ago

Electrical Engineer – Research & Development

Boston, MA $80,000.00-$140,000.00 3 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.