Engineer, Research

********* LOCAL CANDIDATES TO MINNETONKA, MN OR OPEN TO RELOCATE**** NO C2C*******

Job Title: Engineer, Research & Development

Location: Minnetonka, MN (ON-SITE)

ID# SEDAA 42525

PAY RANGE:  50K - 64K/Annum

Description:

A qualified professional to lead and support medical device development projects through comprehensive project management and technical expertise. This role involves developing and maintaining detailed project plans, budgets, schedules, and risk registers to ensure successful execution and alignment with organizational goals.

• The candidate will contribute to the design and development of medical devices, ensuring that all products meet defined specifications and comply with applicable regulatory standards. Collaboration with engineering, quality, and regulatory teams will be essential to drive innovation and maintain compliance throughout the development process.
• Strong communication and collaboration skills are critical, as this role requires facilitating effective interactions among cross-functional teams and stakeholders. The ability to foster alignment and transparency across departments will be key to project success.
• In addition, the candidate will participate in and oversee product testing and validation activities to ensure that devices meet performance, safety, and quality requirements. Coordination with relevant teams will be necessary to support verification and validation efforts.
• Finally, the role includes preparing and maintaining documentation to support regulatory submissions and product lifecycle management. All documentation must be accurate, complete, and compliant with industry standards and internal policies.

********* LOCAL CANDIDATES TO ST. PAUL, MN OR OPEN TO RELOCATE**** NO C2C*******

Job Title:  Test Technician

Location:  Irving, TX (ON-SITE)

ID# SEDAA 42510

Training Days 8:45 to 3:30 Monday 7:00 to 3:30 Tuesday 6:00am to 2:30 next 8 days

PAY RANGE:  30K - 34K/Annum

Description:

Job Summary:

Working under general supervision, this position is responsible for the production of high-quality medical device instruments. This position includes detailed assembly and testing of various electronic components and finished devices in a controlled manufacturing environment.

Job Responsibilities:

• Performs testing of electronic components and assemblies using automated test equipment
• May perform mechanical assembly of electromechanical subassemblies and devices
• Ability to read, comprehend and follow written procedures; understand and follow verbal instructions. May instruct others in the use of all manuals, test procedures and documentation associated with specialized equipment.
• Reads and interprets engineering drawings, schematics and complex test procedures.
• Participates in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics.
• Maintains accurate records to ensure Device History Records and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products.
• Prioritizes work by determining the sequencing and timing of different jobs based on precedence and importance.
• Positively represents the company during tours by demonstrating techniques and sharing appropriate information.
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, ISO or other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Adheres to all environmental, health and safety SOP's, equipment, policies and procedures, including any department specific requirements.
•  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Minimum Qualifications:

• Experience with electronic assembly and test in a medical device industry preferred.
• High School Diploma or equivalency is required, preferred AAS
• 2 or more years experience with electromechanical assemblies/electronic manufacturing, technical certifications, etc. preferred

Preferred Qualifications:

• Experience in troubleshooting equipment, building and or testing of electronic assemblies
• Working knowledge of IPC standards and use of complex tools and equipment specific to functional areas
• Experience in GMP, ISO, and FDA controlled environments preferred
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.
• Ability to work scheduled overtime as required is preferred.
• Ability to hand and lift up to 25 lbs. as needed for specific job functions
• Must be able to sit and/or stand for long periods of time.
• Ability to frequently sit, stand, walk, reach within hands and arm's length, stoop, kneel and crouch.

********* LOCAL CANDIDATES TO ST. PAUL, MN OR OPEN TO RELOCATE**** NO C2C*******

Job Title:  Sr Electrical Engineer
Location:  St Paul,  MN (ON-SITE)
ID# SEDAA 42306
Days/Hours: Mon – Friday 8:00am to 5:00pm

PAY RANGE : 35/hr - 47/hr 

Description:

• Selected Candidate will start ASAP after screenings have cleared.
• Ability to travel approximately 10%, including internationally.

Skills: 

• Relevant work experience in performing the layout, construction, and evaluation of a variety of prototype Printed Circuit Boards, fixtures and tools.
• Demonstrated ability to develop new design features as part of existing systems.
• Documented record of delivering tool engineering information which adds value to management's decision-making process.
• Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks. Advanced personal computer skills, including spreadsheet, word processing, database management, and specialized applications.
• Advanced credential or professional certification in a relevant discipline/concentration desired. Six-Sigma knowledge and experience desired.
• Training and experience in manufacturing processes and methods desired, especially in the manufacturing of medical devices.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 10%, including internationally.

Education: 

• Bachelor's Degree In Electrical Engineering or related engineering field.

Duties:

• Lays out and constructs a variety of prototype tools and fixtures required for development purposes.
• Conducts evaluations, tests and analyses related to feasibility and function.
• Performs troubleshooting and fault isolation activities on a variety of breadboards and hybrids.
• Conducts measurements specified in design verification plans, documents and tabulates results, and provides engineering test reports.
• Documents custom tools with specifications, schematics and mechanical layouts to support document control and tool release.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.