Riverpoint Medical ยท 3 months ago
Senior Design Quality Engineer
Portland, OR
Full-time
Onsite
Mid, Senior Level
3+ years expRiverpoint Medical is a company specializing in the design and manufacturing of premium medical devices. They are seeking a Senior Design Quality Engineer who will be responsible for complaint handling, complaint analysis, and operations quality support while ensuring compliance with global regulatory requirements.
BiotechnologyHealth CareManufacturingMedical Device
Responsibilities
Develops, coordinates, and conducts technical product/design validation/verification studies and evaluations of engineering design concepts
Integral member of new product development team responsible for leading activities required to ensure reliability and quality of the design and manufacturability of the product. Supports ongoing global regulatory compliance including submissions and audits (MDR, ISO 13485, FDA CFRs, etc.)
Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability
Completes hazards and risk analysis studies of design and processes using ISO 14971, FMEA, and other risk management principles
Compiles and analyzes complaints, performance reports, and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes for improvements in existing or new products
Drives CAPA and Nonconformance investigations and ensures that corrective measures meet acceptable standards. Works cross-functionally to achieve optimal results
Analyzes preliminary plans and develops quality assurance programs to achieve company, customer and governmental agency reliability objectives
Ensure Design Requirements Flow down, predictive modeling, and DRM (Design for Reliability and Manufacturability) are applied
As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing and specifies minimum number of samples to obtain statistically valid data
Utilize problem solving tools using Define, Measure, Analyze, Improve, and Control (DMAIC) methodology
Navigate FDA QSR 21 CFR part 820, EU MDR, and ISO 13485 regulations
Coordinate planning, implementation and trending of multiple quality management systems including CAPA, SCAR, and non-conformances
Performs supplier audits
Leads component qualifications/FAIs to ensure supplier and component requirements perform as intended, as required
Coordinates document change process and documents
Ensures device master record, device history record, risk management file are established and meet all production requirements for commercial release
Qualification
Required
Bachelor Degree in Engineering or similar
CAPA planning and implementation
Use of Failure Mode Effects Analysis (FMEA)
Work experience in an ISO13485 or FDA regulated environment
Computer skills, including Word and Excel
Demonstrated technical writing skills
3+yrs experience in design assurance or design quality in new product development in an FDA regulated environment is desirable, with an understanding of cGMP, QSR, ISO13485, MDSAP, and MDR
Benefits
Medical, Dental and Vision
Life and Accidental Death Insurance
401(k) with company match and immediate vesting
Paid Time Off
8 company paid holidays
Referral Bonus
Annual Bonus
Company
Riverpoint Medical
Riverpoint Medical is a manufacturing company.
201-500 employees
H1B Sponsorship
Riverpoint Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2019-06-28Acquired
Leadership Team
D
Doug King
Chief Executive Officer
Recent News
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