Staff Engineer, Design QA, Hardware - Acton, United States - Insulet Corporation

Insulet Corporation Acton, United States

3 weeks ago

Description

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform.

In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations.

Our continued success depends on itJob Title:
Staff Engineer, Design QA, Hardware & Embedded SW SystemsDepartment: Design Quality AssuranceFLSA Status: Exempt

Position Overview:

The Staff, DQA Engineer will support Design Assurance and Quality Engineering activities throughout the Development Lifecycle for new product development initiatives involving Hardware and Embedded Software Systems for Insulet Corporation.

This includes ensuring that the development process is compliant with applicable standards, regulations and guidance documents for medical devices containing Embedded Software.

This role will interface with other Insulet departments (e.g. Research and Development, Lifecycle Engineering, Operations, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and services to support our medical devices, partner integrations, and data analytics.

Responsibilities:

Key member of cross functional development teams supporting development efforts for Hardwareand Embedded Software Systems.
Provide guidance and support in Design Control to support the development organization. Provideoversight and support for the generation, review, and approval of all Design History File deliverables.
Support Risk Management Activities for complex systems in compliance with ISO14971.
Ensure compliance to the Software Development Life Cycle (IEC and FDA Guidance onSoftware Contained in a 510(k) Submission for Products containing embedded software.
Support efforts for cybersecurity risk management for both US and Rest of World (ROW)requirements.
Provide guidance and support to the development organization on the generation and review ofrequirements & specifications, design documents, design verification plans, protocols, and reports,traceability matrices and other documentation as required.
Provide technical expertise to Design Quality Assurance Organization supporting new productdevelopment and lifecycle engineering initiatives.
Support quality related process/product improvement initiatives throughout the DevelopmentLifecycle and DQA activities within the organization to align with industry best practices

Education and Experience:

Minimum Requirements:

BS degree, in Engineering/Scientific/Applied Science or equivalent experience.
A minimum of 7 years work experience in Design Assurance/Quality/Product Design andDevelopment within an FDA, ISO, or other regulated environment and/or equivalent combination ofeducation and experience.
Proven experience delivering successful products to market.
Subject Matter Expert in Design Controls (FDA 21 CFR Part 820), and Design and Development/Product Realization (ISO
Proficient with Medical Device regulations (IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDAguidance documents on software development, and cybersecurity).
Strong project team skills; experience and capability working collaboratively under a QualityManagement System (QMS), as part of a cross-functional team that includes development,verification/validation, manufacturing, marketing, clinical, regulatory and quality experts

Preferred Skills and Competencies:

Master's degree preferred.
ASQ, CSQE or other quality certificates are preferred.
Demonstrated ability to collaborate with individuals at multiple levels across the organization.
Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
Strong analytical and problem-solving skills.
Able to work effectively in a high-stress, high-energy environment

Physical Requirements:

NoneTravel:

Occasional travel may be required to support development programs

NOTE:
This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days)

#LI-hybridAdditional Information:

The US base salary range for this full-time position is $111, $168, Our salary ranges are determined by role, level, and location.

The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US.

Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process.

Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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