Getinge · 10 hours ago
Design Quality Engineer
Boston, MA
Full-time
Hybrid
Entry, Mid Level
$100K/yr - $110K/yr
1+ years expGetinge is dedicated to making life-saving technology accessible for more people. The Design Quality Engineer will ensure the quality and compliance of medical device products throughout the design and development lifecycle, collaborating with cross-functional teams to implement design control processes and risk management activities.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Implement and maintain design control processes in accordance with applicable regulatory standards (e.g., ISO 13485, ISO 14971, FDA QSR, MDR) to ensure the development of safe and effective medical devices
Lead and contribute to risk management activities throughout the design process, including the identification, assessment, and mitigation of potential risks. Work closely with the R&D team to integrate risk management into the design process
Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending
Develop and execute quality plans for new product development projects, outlining quality objectives, deliverables, and verification/validation activities
Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements
Validate that design outputs meet the specified design input requirements
Manage design changes by assessing their impact on product quality, ensuring proper documentation, and obtaining necessary approvals
Develop and execute protocols for design verification and validation strategies and acceptance criteria
Collaborate with testing teams to ensure thorough testing of product designs
Work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to facilitate effective communication and collaboration throughout the product development process
Stay abreast of relevant regulations and standards and ensure that product designs comply with applicable requirements. Support regulatory submissions as needed
Identify opportunities for process improvements within the design control system and contribute to the development and implementation of best practices
Qualification
Required
Bachelor's degree in engineering or a related field
Minimum of 1-3 years of experience in a quality engineering role in the medical device industry
In-depth knowledge of design control processes, risk management, and quality management systems (ISO 13485, ISO 14971, FDA QSR)
Strong technical skills related to product quality including VOE translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics
Strong understanding of regulatory requirements for medical devices (FDA, EU MDR, etc.)
Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions
Able to travel domestically and internationally as required
Preferred
Advanced degree preferred
DFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus
Electrical and mechanical background strongly preferred
Experience creating and analyzing charts in Minitab, JMP, or equivalent software a plus
Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus
Computer proficiency in MS office (specifically Excel)
Effective verbal and excellent technical writing skills
Excels at generating and maintaining organized and accurate records
Excellent oral and written communication skills in English
Benefits
Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge 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)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
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