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Gilero, A Sanner Group Company · 3 weeks ago

Associate Design Transfer Engineer – Medical Devices

Pittsboro, NC

Full-time

Onsite

Entry Level

1+ years exp

Gilero, a Sanner Group company, is an international contract engineering firm specializing in the design and manufacturing of medical devices. They are seeking an Associate Design Transfer Engineer to support the late-stage development and transfer to production of medical devices, focusing on verification, validation, and documentation to meet state-of-the-art requirements.

ManufacturingMedical DevicePharmaceuticalProduct Design

Growth Opportunities

No H1B

Hiring Manager

Tricia (Grabfelder) Lucas, MBA

Responsibilities

Support product development deliverables through the entire development lifecycle, with a focus on manufacturing transfer

Assist with IQ, OQ, and PQ activities/executions

Support technical risk tracking, providing engineering input, and seeking feedback and mentorship from senior engineers

Help support the development team through technical risk retirement. Support the team on technical risks through step-by-step simplification to discover root cause

Create, review, and release documents according to Gilero’s QMS and the lifecycle of the project and develop manufacturing test methods and inspections to fulfill state of the art requirements

Keep project managers informed on technical projects variables and status

Support project managers by leading smaller, technically oriented projects

Prepare documentation to support design history files and regulatory submissions

Analyze test data, interpret results, formulate conclusions, and apply statistical techniques (t-test, ANOVA, UCL/LCL, Tolerance Intervals)

Support draft Risk documentation through understanding of Risk, Risk analysis, & Risk Burn Down

Support delivery of project objectives and milestones

Support testing campaigns, test flows, sample size analysis, and justification, based on sound judgment, Risk analysis, and QMS requirements

Support product and process risk assessments, including hazard analysis, FMEAs and residual risk analysis in conjunction with Quality Engineering

Write and execute protocols for design verification and validation

Support test method development and validation

Perform testing and inspection of prototypes and pre-production products including assisting assembly for DV&V builds and clinical builds

Support investigation of device failures, coordinate resources, determine root cause, identify corrective actions, and document in conjunction with Quality Engineering

Qualification

Medical device experienceRisk analysisISO 13485Design verificationStatistical techniquesGDP understandingTechnical documentationCommunicationTeam collaborationProblem-solving

Required

BS in Engineering or equivalent technical degree

1+ years relevant working experience in product development, intern or co-op experience

Understanding of good GDP

Exposure to ISO 14971, 13485 and CFR 21

Ability to support and document appropriate scenarios for rationale-based decisions versus testing-based approaches

Ability to author scientific/logic-based rationale

Ability to review, understand, and distill technical standards (ISO, ASTM, IEC, etc.)

Excellent communication skills (oral and written)

Meets Gilero Core Values: Collaboration, Integrity, Innovation, Excellence

Comfortable and productive in a fast-paced, entrepreneurial environment

A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high-quality service to internal and to external clients

Commitment to excellence and quality service to external and internal customers

Follow established policies and procedures, while contributing to continuous improvements

Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future