Senior device engineer job description

Ventura Solutions is a rapidly growing medical device and pharmaceutical staffing, consulting, and training firm. We believe that the best way to advance healthcare is through innovation and continuous improvement. We value our commitment to solving healthcare's toughest problems and delivering world-class products, services, and human resource solutions. We are a company of problem solvers, inventors, teachers, and friends.

Our company offers an energized, collaborative, optimistic, and fun culture that cultivates an inventive spirit while being committed to exceeding client expectations. For more information about us visit us at www.ventura-solutions.com

Are you an Exceptional Medical Device Engineer looking for a new opportunity with an innovative and growing Medical Device consulting firm?

If you consider yourself to be an engineer with excellent experience in Medical Devices, Product Development, Design Controls, and Risk Management – we want to meet you!

Experience and passion are what we desire for this role and we're looking for the best! While working in this role you will have the ability to:

The Senior Engineer will utilize their engineering/technical skills and experience to drive the development and maintenance of medical devices. This position will involve creating Design History File (DHF) specifications and ensuring compliance to CFR 820.30 Design Controls and ISO 14971 Risk Management. The engineer will collaborate with other functional team members on researching requirements, driving design verification and validation, and human factors, along with owning all the DHF and risk management deliverables to ensure the safety and efficacy of new and existing products.
Responsibilities
As a Senior Engineer, you will utilize your engineering and research skills to drive innovative new product development and remediate and maintain existing product lines by creating, managing, and analyzing DHF specifications, product risk management files, and other associated engineering design files. Specifically, depending on the project assignment you will:
Participate in focus groups and in early use case development to identify unmet needs for design & engineering concept development. Work with marketing teams to clearly define unmet needs and User Needs for upstream product development efforts. Lead the development of Design History Files (DHF) and Risk Management Files. Research device clinical use, standards, and other relevant regulatory guidance documents to support new product development and regulatory submissions with compliance to governing procedures, 21CFR 820.30 Design Control and ISO 14971 Risk Management for medical devices. Research industry best practices and define state-of-the-art for new and existing products. Analyze product complaints and standards to create robust design inputs and user needs Partner with other functions including Manufacturing, Safety/Clinical, Human Factors, Quality, Regulatory, and Design Engineering to lead and perform risk assessments. Develop FMEAs to ensure failure modes and patient risks are identified & mitigated; lead risk management activities; provide risk and design control input to cross-functional teams. Supports medical device inspection readiness and regulatory responses as needed. Support the completion of gap assessments against industry regulations or standards. Extract and summarize scientific information from internal studies to identify details required for regulatory submissions, regulatory responses, and inspection readiness. Lead design verification and validation.
Qualifications
Bachelor's degree in engineering with a minimum of 1 year of experience. Medical Device experience. An Engineering degree in Biomedical, Mechanical, Chemical, or Industrial engineering is a great fit, but other engineering degrees will be considered. Experience creating and maintaining Design History Files (DHF) and ensuring compliance to CFR 820.30 Design Controls and ISO 14971 Risk Management.
Basic understanding of engineering principles, system design, traceability, and risk management. Experienced with performing risk assessments using a variety of tools. Experience leading other engineering disciplines to execute and able to support product development technical challenges. Experience with design verification and validation. Experience with change control and design transfer. Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues. Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgment.
Preferred, but not required, Qualifications
Combination Product Experience. Strong statistical analysis skills, Design of experiments (DOE), Minitab. EU and MDR experience with medical devices or combination products. Extensive experience in risk management and design control of medical devices or combination products from concept through launch. Experience or familiarity with drug product development practices required for clinical trials and commercial products. Have experience working with third-party development partners. Experience with SAMD (Software as Medical Device). Understanding of recognized consensus standards for single-use combination products related to but not limited to biocompatibility, particulate, sterility etc. Experience with human factors engineering. Creation of use error risk analysis reports, usability assessments, human factors plans, and human factors reports. Experience with prefilled syringes or autoinjectors. A combination of strong pharmaceutical, combination products, and medical device development experience is preferred. Experience with the ISO-11608 series of standards. Broad technical knowledge related to the design/operation of drug combination product platforms, design control, risk management, ISO 14971/24971, and 21 CFR 820.
Key Leadership Competencies
Strong Communication Skills. Builds strong relationships with peers and cross-functionally with partners to enable higher performance. Strong leadership, negotiation, interpersonal, communication, and facilitation skills. Learns fast, grasps the "essence" and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo. Creates a learning environment, open to suggestions and experimentation for improvement. Proven ability to succeed in a fast-paced, challenging, and complex environment. Embraces the ideas of others, nurtures innovation and manages innovation to reality. Strong interpersonal and communication skills with demonstrated ability to work within a team environment.
If you can say YES to the above requirements, we want to talk to you – APPLY NOW! We would love to talk about your experience, career goals, and fit with this amazing role.
Location
Libertyville, Illinois
Employee Type

W2 Employee
Benefits
Choice of medical dental and vision plans Paid Vacation Time Competitive base salary
This is a great opportunity and we're looking to fill this role with the right person. If you are ready to embark on an amazing new career opportunity, APPLY RIGHT NOW!
Offering world-class solutions for our clients is only part of our mission. Providing a rewarding and fulfilling place to work is a top priority for us. From an industry-leading compensation package to a focus on work-life balance, we offer a challenging and flexible place to achieve your career dreams. Make your impact today!
Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Rocket Lab is a vertically integrated provider of small launch services, satellites, and spacecraft components. Our mission is to open access to space to improve life on Earth. Our team is over 1,300 people strong and we're adding to it every week. Collaboration is at our core – every idea is heard, and everyone makes a difference. Teams are nimble, decisions are made quickly, and we are action oriented.

NEUTRON

Neutron is a medium lift launch vehicle capable of delivering the mega constellations of tomorrow, high assurance payloads, and human spaceflight. As a highly reusable launch platform, Neutron will deliver a highly cost-effective and reliable launch solution leveraging Rocket Lab's proven execution history with the Electron program. If you're interested in joining a high performing team, pushing the boundaries with a clean sheet development of re-usable liquid launch vehicle, this is your opportunity!

Senior Propulsion Combustion Devices Engineer, Neutron

Based out of Rocket Lab's our headquarters in Long Beach, CA the Senior Propulsion Combustion Devices Engineer, Neutron is responsible for the design, development, manufacturing support for one or more of a variety of combustion devices (injectors, thrust chamber, preburners, etc. for the Archimedes Engine. In this role you'll have opportunities to take ownership of a component from design through to implementation. You will support the Neutron and Archimedes teams, with deliverables required for internal leadership, board of directors, and investors.

WHAT YOU'LL GET TO DO:

• Define requirements, test plan, flight qualification plans for combustion devices.
• Work with turbomachinery, engine systems, manufacturing and testing groups to design and manufacture hardware.
• Design, analyze, and perform trades studies to achieve design goals
• Work with manufacturing teams to support fabrication, design for manufacturability and resolve issues that may arise during prototype builds.
• Work with the test and launch teams to develop, qualify, fly, and re-fly your hardware.

YOU'LL BRING THESE QUALIFICATIONS:

• Bachelor's degree in an engineering discipline or equivalent
• 5+ years of combustion device design experience or similar role
• Knowledge of heat transfer, fluids and structural mechanics
• Fundamental understanding of mechanical design principals

THESE QUALIFICATIONS WOULD BE NICE TO HAVE:

• Master's degree
• Proficiency in GD&T
• Professional experience with NX, Ansys, or similar tools.
• Rocket combustion devices
• Experience with best practices for design, qualification and production
• Experience with a scrappy development environment

Important information:

FOR CANDIDATES SEEKING TO WORK IN US OFFICES ONLY:

To conform to U.S. Government space technology export regulations, applicant must be a U.S. citizen as defined by ITAR (22 CFR §120.15) or eligible to obtain the required authorizations from the U.S Department of State.

Rocket Lab provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment at Rocket Lab, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Responsibilities

Peraton is hiring a Senior Mobile Device Design Systems Engineer to join our Cyber Mission business unit in Linthicum, MD. As a Systems Engineer on our team, you will support one of the largest enterprise-wide engineering contracts within the Intelligence Community. This is a full-time position requiring 1880 hours of support per year; and work is performed at a customer location. As a Senior Mobile Device Design Systems Engineer on our team you will support a customer Program Management Office (PMO) tasked with delivering products and services that leverage our technical expertise to improve the nation's cybersecurity posture. The individual will provide general systems engineering support including creating the following comprehensive documentation for a new assurance process for secure mobile device:

• Standardization
• Analysis of Alternatives
• Meeting minutes
• Summaries of technical discussions
• Test result reports
• Draft and finalized SOPs, descriptions, and guides to using the new assurance processes

Qualifications

Individual Capabilities/Experience Required:

• Submitted candidates must meet the minimum experience and education requirements to qualify for the Systems Engineer Level 6 (SE 6) labor category. Bachelor's degree in computer science, information systems, engineering or other related discipline plus at least 20 years of systems engineering experience. A Master's degree or PhD may be substituted for two years of experience. A high school diploma or GED plus 24 years of systems engineering experience would also be acceptable.
• Position requires TS/SCI clearance with polygraph

#LI-AH1

Individual Capabilities/Experience Desired:

• Experience in applying systems engineering and integration support to a large Agile/DevOps environment.
• Knowledge of SE Best practices and innovative approaches to applying those practices in a fast paced ongoing development environment.
• Solid application of SE throughout the lifecycle of a development effort.

Applicants selected will be subject to a government security investigation and must meet eligibility requirements for access to classified information.

Peraton is an Equal Opportunity/Affirmative Action Employer. We consider applicants without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status, or membership in any other group protected by federal, state, or local law.

Peraton Overview

Peraton drives missions of consequence spanning the globe and extending to the farthest reaches of the galaxy. As the world's leading mission capability integrator and transformative enterprise IT provider, we deliver trusted and highly differentiated national security solutions and technologies that keep people safe and secure. Peraton serves as a valued partner to essential government agencies across the intelligence, space, cyber, defense, civilian, health, and state and local markets. Every day, our employees do the can't be done, solving the most daunting challenges facing our customers.

An Equal Opportunity Employer including Disability/Veteran.

For Colorado Residents Colorado Salary Minimum: $102,100
Colorado Salary Maximum: $247,800

The estimate displayed represents the typical salary range for this position, and is just one component of Peraton's total compensation package for employees. Other rewards may include annual bonuses, short- and long-term incentives, and program-specific awards. In addition, Peraton provides a variety of benefits to employees.