Senior Systems Engineer

Insulet Corporation Billerica , MA 01821

Posted 3 months ago

Position Summary

The Sr. Systems Engineer will be a technical lead in the design and development of Insulet's products. This position will be an integral member of the R&D team leading systems engineering activities while directly supporting the product development phases of Insulet's innovation pipeline of wearable pump technology. This role will dive into several aspects of Insulet's development processes including but not limited to defining product requirements, system integration, troubleshooting/design analysis, and design documentation.

Responsibilities

  • Serve as the lead Systems Engineer of a cross-functional project team consisting of mechanical, electrical, software, manufacturing, and quality engineers to achieve program deliverables.

  • Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions.

  • Contribute to system development by defining system, subsystem architecture and design for manufacturing.

  • Identify and document system hazards, failure modes, and risk mitigations.

  • Work with the technical centers of excellence domain subject matter experts, and suppliers in the assessment, selection, integration, and qualification of key components and subsystems.

  • Serve as technical consulting resource for integration, subsystem and system verification activities creating plans, protocols and reports as necessary.

  • Oversee engineering evaluations & data analysis reviews.

  • Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts of the design in compliance with FDA guidelines.

  • Support the preparation of proposals, program plans, estimates, and present information and status to leadership and other stakeholders.

  • Contribute to team goals by accomplishing related tasks as required.

Education and Experience

Education and Experience:

  • A Bachelor of Science or equivalent degree in Systems Engineering, Mechanical Engineering, Electrical Engineering or Biomedical Engineering is required, a Master of Science degree is desired; System Engineering training and/or certification is a plus.

  • A minimum of six (6) years' experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment.

  • 2+ years of experience in leading a development/technical team.

  • Domain expertise in one of more associated domains; preferably Electrical or Mechanical Engineering, with exposure to Software, Quality, and Test Engineering

  • Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments

  • Comprehensive understanding of verification plans, protocols and reports in a regulated industry.

  • Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.

  • Ability to communicate at multiple levels of an organization

  • Ability to organize and judge priorities in a dynamic environment

Preferred Qualifications

  • Experience or formal training in established Systems Engineering concepts.

  • Experience with long term R&D development programs (concept/feasibility, development, commercialization)

  • Experience with embedded software implementation, mobile technologies, wireless communications, IoT

  • Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS.

  • Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).

  • Working knowledge of requirements lifecycle management tools (i.e. Helix ALM, Doors, Arena PLM)

  • Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market.

Physical Requirements (if applicable):

  • Must be able to sit or stand for 8 hours a day
icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Systems Engineer

Alert Innovation

Posted 2 weeks ago

VIEW JOBS 1/3/2020 12:00:00 AM 2020-04-02T00:00 <p>Full Time, Exempt</p><p>As a Systems Engineer, you will play a critical role in helping provide the business knowledge and technical skills to implement technical strategies, evaluate products, and provide a superior level of technical cross functional support that benefits the company. </p><p>You will be part of a talented team of engineers that demonstrate superb technical competency, possess the interpersonal skills to collaborate with project managers and leadership to effectively deliver a product designed to meet customers’ needs. Qualified Systems Engineers at Alert will have a background in robotics engineering or systems engineering and analysis. Alert Innovation offers a competitive salary, generous benefits and an equity stake in our growing company.</p><p>Alert Innovation offers a competitive salary, generous benefits and an equity stake in our growing company.</p><p><strong>WHAT WILL YOU LOVE?</strong></p><ul> <li>Being a part of an organization that is innovative in both its products and the design of the organization.</li> <li>Being a partner in the realization of our vision of a high-performance culture in an adaptable organization.</li> <li>Solving complex problems and making significant impacts to the capabilities of the product.</li> <li>Working in a fast paced, flexible environment where there is no wrong answer and everyone works for the same team.</li> </ul><p><strong>WHAT WILL YOU DO?</strong></p><ul> <li>Creation of theory of operation documents for NPI and customer deployments</li> <li>Creation and maintenance of requirement document for new product designs and customer site deployments with information collected from both internal and external resources</li> <li>Creation of traceability matrix of higher-level requirements to lowest level requirements</li> <li>Creation and maintenance of system integration test plans, procedures, and reports to demonstrate desired system performance and validate system requirements</li> <li>Actively participate and / or lead in the discovery, validation, verification process throughout the product or component development life cycle</li> <li>Execution of system integration, verification and validation testing including customer acceptance to verify system requirements </li> <li>Perform functional and performance analysis on collected system data; document, root cause and resolve observed issues, anomalies, and provide trouble reports.</li> <li>Lead project teams for system improvement projects or customer requested features and create and maintain schedules to drive on-time delivery</li> <li>Proactively initiate engagement with cross functional teams to review concurrence and compliance in functional disciplines including hardware, software, QA, safety, reliability, maintainability, testability, and manufacturing, ensure product managers, technical leads, and project managers stay informed and aligned as requirements mature</li> <li>Creation of material and presenting in customer meetings</li> <li>Provide feasibility and optimization studies for proposed designs</li> <li>Creation of tools that automate and streamline processes to make operations more efficient</li> <li>Aid in the development of strategic roadmaps for products and systems</li> <li>Perform quality assurance activities to ensure standardization of best practices</li> </ul><p>WHAT ARE WE LOOKING FOR?</p><ul> <li>Bachelor’s degree in a related Engineering field or equivalent experience</li> <li>Experience with project management and schedule ownership for multi-disciplinary project teams</li> <li>Minimum of 5 years of relevant work experience</li> <li>Ability to provide technical oversight to ensure developed solutions satisfy customer and business requirements</li> <li>Ability to resolve customer issues or difficulties in a manner that is consistent with our company mission, values, and financial objectives</li> <li>Ability to identify, evaluate, and demonstrate solution to complex system problems</li> <li>Cross disciplinary engineering knowledge – some experience in mechanical, electrical, and software engineering</li> <li>Familiarity with automation components</li> <li>Experience with common engineering tools, including Pugh Matrices, 8D, DFMEA</li> <li>Proficiency in Microsoft Office suite</li> <li>Excellent written and verbal communication skills</li> <li>Comfort with a fast-paced environment</li> <li>Ability and willingness to travel to project sites</li> <li>Willingness to accept ownership for project goals and perform any and all tasks necessary to achieve project goals</li> <li>Self-motivated and capable of working with minimal supervision to achieve aggressive project goals</li> </ul><p>TEAMING AND PERSONAL<br></p><ul> <li>Constructively support or lead project teams as the circumstances require or as assignment by team leads</li> <li>Work successfully in a collaborative team environment</li> <li>Constructively influence team decisions and product design requirements</li> <li>Self-motivating and capable of working without direction or supervision to achieve team goals</li> <li>Excellent written and verbal communications skills and be able to communicate across all levels of the organization</li> <li>Possess the additional skills of business acumen, basic team facilitation, assignment flexibility, independent thinking and responsibility for execution</li> </ul><p>VALUES</p><ul><li>All members of Alert Innovation practice the following values as part of their daily responsibilities and model these values as she/he leads or supports their teams.<ul> <li>The Golden Rule: Extraordinarily powerful in its simplicity and depth: “Treat others as you would want to be treated”</li> <li>The Power of Person: The contribution of every single person in a company is important, and the performance of the entire company can only be maximized when every person strives to achieve his/her full potential and to contribute to the best of his/her ability</li> <li>The Power of Team: The Power of Person becomes amplified exponentially when a group of people working effectively as a team create “performance synergy”, whereby the capacity to perform as a team is much greater than the sum of the individual members’ capacities</li> <li>The Power of Truth: We strive to see the world as it is, not as we want or imagine it to be, because only then can we make it better. This core value manifests itself through questioning, probing, testing, measuring, validating, verifying, proving, listening with an open mind, and making fact-based decisions. It also fosters transparency and honesty with others, as well as self-examination and self-honesty</li> </ul> </li></ul><p>Alert Innovation offers a highly competitive salary for each job family and level within the Boston-area market in which we are based. As part of our Power of Truth value we practice salary transparency, so you know you are being compensated fairly relative to other team members performing similar roles in our organization.</p><p>Every employee is granted stock options which vest over four years. We have 31 issued or pending patents on our groundbreaking technology. A leading retail equity analyst at Jefferies recently published that “we view Alert Innovation’s fulfillment technology as the most diverse and comprehensive. In addition, its developing the Novastore concept could be a winning long-term format.”</p><p>We offer full time employees a generous benefits package starting with your date of hire.</p><p>PAID TIME OFF</p><ul><li>No fixed limits on the number of workdays that you can take off for personal reasons, including vacations. You take what you need keeping in mind the demands of your team’s workload.</li></ul><ul><li>9 Paid Holidays.</li></ul><p>MEDICAL/DENTAL/VISION</p><ul> <li>Blue Cross Blue Shield HMO and PPO options.</li> <li>Health Reimbursement plan where Alert Innovation reimburses you for deductible related expenses ($1,000 for individuals, $2,500 for families).</li> <li>Dental insurance thru Delta Dental of MA.</li> <li>Vision Plan thru VSP.</li> <li>Flexible Spending Account to enable you to pay health care and dependent care costs on a pre-tax basis.</li> </ul><p>INSURANCE</p><ul> <li>Group Term Life Insurance at no cost to you, equal to three times your annual salary.</li> <li>Accidental Death and Dismemberment Insurance at no cost to you, equal to three times your annual salary.</li> <li>Short Term Disability Income Protection at no cost to you, equal to 70% of your weekly salary for up to 13 weeks.</li> <li>Long Term Disability Income Protection at no cost to you, equal to 66.67% of your monthly earnings.</li> </ul><p>RETIREMENT</p><ul><li>401k Plan administered by Fidelity to enable you to save using pre-tax dollars.</li></ul><p>PERSONAL/CAREER DEVELOPMENT</p><ul> <li>100% of cost of training for your current or near-term work needs including conferences and technical events.</li> <li>50% reimbursement of tuition for programs aligned with career development goals including MBA and master’s from top schools (online via Coursera).</li> <li>50% reimbursement of Nano Degrees (online via Udacity).</li> <li>Earn a Bachelor’s or Associates college degree from a fully accredited undergraduate program for only $5,000/year through our College For America benefit with Southern New Hampshire University.</li> </ul><p>OTHER</p><ul> <li>Daily catered lunch at no cost to you.</li> <li>Employee Assistance Program to assist with emotional health, parenting, eldercare, nutrition, legal and financial consultation needs.</li> </ul><p>The above list is only a summary of some of our benefits and is not meant to be a comprehensive explanation.</p><p>Alert Innovation is proud to be an Equal Employment Opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.</p><ul> </ul> Alert Innovation North Billerica MA

Senior Systems Engineer

Insulet Corporation