What are the responsibilities and job description for the Senior Design Quality Engineer (Hardware & Software) - Rochester, NY (Onsite) position at Shiro Technologies?
We are seeking an experienced Senior Design Quality Engineer (Hardware & Software) to join a Global Quality & Compliance organization supporting product development initiatives within regulated environments. This senior-level individual contributor role provides technical leadership in Design Controls, Risk Management, and Quality Engineering activities across hardware, software, and integrated systems.
The ideal candidate will ensure that user needs, design requirements, and product claims are scientifically justified and translated into robust, testable acceptance criteria that support safe and effective product performance. This role partners closely with cross-functional teams to drive quality excellence throughout the product lifecycle while ensuring compliance with global regulatory standards.
Key Responsibilities
Support complex Quality Engineering activities that align with business objectives and regulatory requirements.
Provide expertise in Design Controls and Risk Management throughout the product development lifecycle.
Ensure compliance with applicable regulations and standards, including ISO 13485, FDA 21 CFR 820, IVDR, and related requirements.
Collaborate with cross-functional teams including R&D, Regulatory Affairs, Manufacturing, and Supply Chain to integrate Quality principles into product development processes.
Lead Quality activities related to design changes, validation strategies, and product claim verification approaches.
Drive continuous improvement initiatives focused on process optimization, harmonization, standardization, and digital enablement within Quality Management Systems (QMS).
Maintain a high level of inspection readiness and serve as a Quality representative during regulatory inspections, notified body audits, and internal audits.
Identify and communicate Quality risks, recommendations, and project status updates to stakeholders and leadership teams.
Provide coaching, mentoring, and technical guidance to peers, junior engineers, and project teams.
Contribute to organizational capability development by promoting scientific excellence, compliance, and continuous improvement.
Perform additional Quality-related responsibilities as assigned.
Required Qualifications
Bachelor''s degree in Life Sciences, Engineering, or a related technical discipline.
Minimum 5 years of progressive experience in Quality, Compliance, or related functions within Medical Device, In Vitro Diagnostics (IVD), or Biopharmaceutical industries.
Strong knowledge of Quality System regulations and standards, including:
ISO 13485
FDA 21 CFR 820
IVDR
Experience supporting Design Controls and Risk Management activities within regulated product development environments.
Demonstrated success leading Quality and Compliance initiatives aligned with regulatory expectations and business objectives.
Strong analytical and problem-solving abilities with experience leveraging data to support decision-making and process improvements.
Excellent interpersonal, communication, collaboration, and influencing skills across cross-functional teams.
Commitment to scientific integrity, compliance excellence, and continuous improvement.
Preferred Qualifications
Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline.
Experience implementing, optimizing, or maintaining global Quality Management Systems (QMS) and associated digital tools.
Lean Six Sigma, PMP, or similar certifications demonstrating process improvement expertise.
Experience supporting or leading Health Authority inspections and Notified Body audits.
Experience with integrated hardware and software systems within regulated environments.
Ideal Candidate Profile
Strong background in Design Quality Engineering within Medical Device or IVD industries.
Hands-on experience with Design Controls, Risk Management, and regulatory compliance.
Ability to operate effectively in fast-paced, highly regulated environments.
Excellent leadership and mentoring capabilities without direct people management responsibilities.
Proven track record of driving quality improvements while supporting innovation and business growth.