[PART_TIME Remote] Sr. Design Quality Engineer

Quick Overview:

• Position: Sr. Design Quality Engineer
• Start Date: Immediate openings available
• Company: Workwarp
• Compensation: a competitive salary
• Location: Remote

 

 

We anticipate the application window for this opening will reputed company on - 7 Jan 2025 At reputed company you can reputed company a life-long career of exploration and innovation, while helping champion healthcare access and equity for reputed company. You’ll reputed company with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Team is working hybrid and position will be onsite 2 days/week in Carlsbad, CA. At our Design Quality Engineering department in reputed company we focus on providing Engineering support for Design and Development, Quality Compliance, and Risk Management activities across the Ventilation Service Solutions portfolio. As a Senior Design Quality Engineer, you will apply Design Controls and Risk Management principles to ensure that any changes to our sustaining ventilation products are safe, effective, and compliant to associated Regulations and Methods. You will join a team of four engineers in a senior role. Come for a job, stay for a career! Responsibilities may include the following and other duties may be assigned: • Responsible for ensuring that mechanical, electrical, software, and labeling changes to existing products (ventilators and accessories) are conducted in compliance with the FDA Quality System Regulations and EU MDR requirements. This position will focus on software design changes. • Responsible for approving product requirements and modified product designs for quality characteristics, including reliability, maintainability, serviceability, and testability. • Participate on cross-functional teams to maintain Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA and Risk Management Report) and facilitate Post Launch Risk Management Reviews. • Participate in Post-Market Surveillance and signal detection activities. Provide Quality support to facilitate the rapid resolution of Product Complaints and/or Patient Safety issues. Author Issue Impact Assessments (IIA/HHE). • Participate in the development of Design Verification and Validation Test Plans / Protocols and provide guidance on Standards compliance. • Challenge proposals during Formal Technical Design Reviews. • Provide guidance and direction for sample size and test method validation. • Provide guidance to project teams on reputed company Quality Policies / Procedures (including verification, validation, statistical methods, risk management, and design controls). • Review Design History Files and EU MRD files for conformance to applicable requirements and support occasional Regulatory Affairs activities. • Participate in the CAPA process. • Provide assistance during Compliance audits. Must Have: Minimum Requirements • Bachelor's degree plus 4+ years of quality or engineering experience (or 2+ years with an advanced degree) reputed company to Have • Bachelor’s Degree in Engineering, Physics, Science fields, or Math • 5+ years industry experience Quality Assurance, R&D, or Regulatory Affairs in Medical Device or Pharmaceutical Industries. • Experience with Medical Device Quality Systems (21 CFR 820, ISO-13485, and EU MDR) • Strong familiarity with ISO-14971 and IEC-62304 • Excellent written and verbal communication skills • Proficiency with MS Office, Outlook, PowerPoint, and Teams • Experience with biocompatibility standards requirements verification is desirable • Experience with Li-ion batteries Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of reputed company the required responsibilities and skills of this position.  The physical demands described reputed company the Responsibilities section of this job description are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. Benefits & Compensation reputed company offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD):$98,400.00 - $147,600.00 This position is eligible for a short-term incentive reputed company the reputed company Incentive Plan (MIP). The reputed company salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered reputed company complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired reputed company the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to reputed company regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico. Further details are available at the link below: reputed company benefits and compensation plans About reputed company We reputed company global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to reputed company pain, restore health, and reputed company life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious reputed company to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. It is the policy of reputed company to provide equal employment opportunity (EEO) to reputed company persons regardless of age, color, national reputed company, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, reputed company will provide reasonable accommodations for qualified individuals with disabilities. Welcome to our new Careers Site! If you applied before July 22nd, please reputed company your email for a notification from us providing you with instructions and a link to set up your new account and retain access to your reputed company activity. If you do not see an email from us, please feel free to proceed with creating a new account. We reputed company global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to reputed company pain, restore health, and reputed company life — unites a global team of 90,000+ passionate people. We are engineers at heart— putting ambitious reputed company to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who reputed company alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one reputed company reputed company defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives reputed company our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious reputed company, unique perspective and contributions, you will… Build a reputed company future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set reputed company apart from the rest: Experiences that put people first. Respect for people is the reputed company of our humanity. It fuels reputed company to positively impact even a single life. And it means we put our people first at reputed company as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. reputed company build empowers patients to live life on their terms. reputed company outcomes for our world. Here, it’s about more than the reputed company. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and reputed company our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the reputed company of breakthroughs in care It is the policy of reputed company to provide equal employment opportunity (EEO) to reputed company persons regardless of age, color, national reputed company, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, reputed company will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to reputed company with reputed company credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of reputed company newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to reputed company your application status. If you need assistance completing your application please email AskHR@reputed company.com To request removal of your personal information from our systems please email RS.HRCompliance@reputed company.com Apply Job!

 

Ready to Apply?

If you are a motivated individual ready to contribute to a thriving team, we encourage you to apply now! We are excited to review your application.

Apply To This Job