Highlights
Must Have Qualifications Bachelor's Degree in Engineering, Science, or a technical field with 2 years of work experience in Engineering and/or Quality OR an Advanced degree in Engineering, Science, or a technical field in Engineering and/or Quality. Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies.
Numbers & Facts
| Location | Mounds View, MN |
| Industry | Staffing/Employment Agencies |
| Salary | $40 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Join our team in Mounds View, MN, where you will play a crucial role in ensuring the safety and compliance of our cardiovascular surgery products. This is an exciting opportunity to work onsite and collaborate with a dynamic cross-functional team.
Must Have Qualifications
- Bachelor's Degree in Engineering, Science, or a technical field with 2 years of work experience in Engineering and/or Quality OR an Advanced degree in Engineering, Science, or a technical field in Engineering and/or Quality.
- Bachelor's or Master's Degree in Mechanical Engineering, or other related engineering degree strongly preferred.
- Experience in medical device design and application of test standards.
- Experience in applying statistical methods to design reliability and process capability.
- Certified Quality Engineer, Reliability Engineer, or equivalent desired.
- Strong oral and written communication skills.
- Effective cross-functional team player with excellent presentation skills.
- Ability to handle multiple tasks/projects and manage priorities accordingly.
- Working knowledge of appropriate industry standards.
- Ability to work in a team environment and exert influence without alienating others.
- Knowledge/basic understanding of specification development, industry standards, geometric dimensioning, and tolerancing (GD&T), etc.
Responsibilities may include the following and other duties may be assigned:
- Monitor the company's drug or medical devices surveillance program, including the intake, protocol development, evaluation, processing, and follow-up on adverse reports.
- Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or adverse reaction data as required by regulatory agencies.
- Review and analyze clinical databases for the extraction of ADE data and integrate the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization, as well as to ensure the accuracy and quality of safety summaries.
- Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
- Complaint handling experience and knowledge of IMDRF or complaint coding is a plus.
- Map complaint code to categories and update work instructions accordingly.
- Work with a cross-functional team.
3-5 years of relevant experience.
Additional Information
We are looking to hire and start ASAP, with interviews commencing immediately. The role requires onsite work in Mounds View, MN, 4 days a week.
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.