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Job Requirements of Verification and Validation RD Engineer:
-
Employment Type:
Full-Time
-
Location:
Marlborough, MA (Onsite)
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Verification and Validation RD Engineer
Pyramid Consulting, Inc
Marlborough, MA (Onsite)
Full-Time
Immediate need for a talented Verification and Validation RD Engineer. This is a 06+months contract opportunity with long-term potential and is located in Marlborough, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:24-50629
Pay Range: $65 - $67/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy .
#tel J2W:CB3
Job ID:24-50629
Pay Range: $65 - $67/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- For more details -
- Establish equipment requirements by working closely with product design team, suppliers and the multi-functional project team.
- Align the equipment specifications to reliability and quality requirements within the framework of new products development or management of legacy products.
- Apply Analytical and quantitative problem-solving using methods including but not limited to Root Cause Analysis and Design of Experiments.
- Define Manufacturing Process Flow, Master Validation Plan for the overall Manufacturing Process as well as Qualification Strategy for individual equipment.
- Own the DMR for NPI and lead preparation of protocols, test execution and test report for qualification documents including Factory Acceptance Test (FAT), Supplier Acceptance Test (SAT), Installation Qualification (IQ), Process Characterization (DOE), Operational Qualification (OQ), and Performance Qualification (PQ), Process FMEA, Gage R&R, Process
- Capability (Cpk), Statistical Process Control (SPC), Purchase specifications and Quality Control Specifications.
- Publish standard methodologies around Process Development; coach and mentor team members on Lessons Learned.
- Support Manufacturing Engineering Team and Market Support Team for complex issue solving for legacy products (e.g. production issues, customer complaints, customer requests).
- Work in a multidisciplinary Research and Development team, in close interaction with the Production, Supply Chain, Sourcing and Quality departments, as well as suppliers.
- Key Skills:(IQ, DOE, OQ, PQ, Process FMEA), regulations (ISO13485, FDA 21 CFR Part 820), Manufacturing process .
- Bachelor’s degree required. Master’s degree or equivalent in related scientific or engineering fields (mechanics, micro-mechanics, engineering) preferred.
- 5+ years’ experience in designing, developing, transferring and maintaining manufacturing technologies and processes associated with regulated industry (medical device, class II and/or class III).
- 5+ years’ experience in performing qualification and validation of manufacturing process (IQ, DOE, OQ, PQ, Process FMEA).
- Founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.
- Strong organizational and interpersonal skills.
- Familiar with the following manufacturing processes: machining, injection molding, compression molding, tube extrusion, thermoforming, heat staking, heat sealing, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding, automated assembling, labeling, packaging or other related experience.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy .
#tel J2W:CB3
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