Test Engineer with Medical Equipment Experience

Position: Test Engineer Duration: 10 Months (Possible extension) Location: St. Paul, MN 55117

Job Details:

?? Working on capital equipment

?? Will be at the Tech Center

?? Positions will be software focused

?? Software development experience

?? Role will NOT be writing code

?? Authoring protocol

?? Evaluating risk

?? Reviewing of cyber security practices

?? Software test or test reviewing or regulating

?? Someone who has medical device a plus

?? ISO 162304 experience

?? PTC Windchill, Doors, python scripts, integrity - tool experience a plus

?? Electrical or mechanical equipment experience with EP

?? 5+ years of experience

?? BA in electrical, biomedical, computer science or engineering degree

Top skills:

?? Medical device software skills

?? Technical writing

?? Attention to detail

?? How to prioritize day to task

Essential Functions:

?? Ensure companys adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.

?? Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.

?? Manage new product Design History Files.

?? Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.

?? Aide in definition of test equipment as required to accomplish quality responsibilities.

?? Develops and documents test plan protocols, test procedures, and test reports.

?? Perform tests according to various protocol requirements.

?? Lead completion of risk management and risk analysis including FMEA.

?? Devise design verification and design validation plans for products based on performance specifications and risk analysis

?? Analyze and communicate conformance to specifications and standards.

?? Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.

?? Support completion of in vitro testing including applicable animal studies.

?? Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.

?? Assist in specifications and testing of sterilization methods.

?? Lead system and product continuous improvement teams.

?? Reviews Engineering Change Orders, as required.

?? Perform other duties and responsibilities as assigned by senior management.

This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, SPECTRAFORCE and the assigned client reserve the right to revise the job or to require that other or different tasks be performed as assigned.
Pay range: 45$ - 53$ based on experience and skills
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require a reasonable accommodation.