Senior Mechanical Engineer

Description

Supervisor’s Title: Senior R&D Manager

Exempt or Non-Exempt: Exempt

Location: Must be able to work in the Burnsville, MN office

Compensation: The expected annual base salary range for this Minnesota based position is $100,000-$140,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Retirement Benefits).

Basic Function

The Senior Mechanical Engineer leads research and development efforts at the team level. This role involves researching, designing, and developing disposable catheter products to ensure a successful production launch. The focus will be on designing devices that meet customer requirements based on input from the research, marketing, quality, regulatory, and manufacturing departments. Additionally, this position is responsible for adhering to the Imricor Quality Management System requirements and fulfilling duties as outlined in the environmental, health, and safety policies.

Responsibilities

• Applies advanced engineering principles in the design and evaluation of mechanical components and systems.
• Leads the design and development plans at the team level to design, prototype, and refine concepts using engineering principles, human factors/usability, and design for manufacturability practices.
• Consults with internal stakeholders to identify customer needs and translate these requirements into designs. Additionally, provides product development support to internal departments.
• Accountable for successfully launching products through the development process by collaborating with the project team, including design assurance, quality control, manufacturing, regulatory affairs, clinical, and marketing.
• Utilizes SolidWorks to design and interpret prints, technical drawings, and schematics.
• Prepares and presents technical information to a technical and non-technical audience.
• Provides training and work direction as required to technicians and junior engineers.
• Delivers high-quality deliverables that comply with various geographic regulations.
• Creates prototypes and conduct testing to ensure design performs as expected.
• Works with suppliers and manufacturing departments to ensure final design is properly realized based on the design intent.
• Creates and executes change orders to document and implement changes.
• Evaluates and manages cost of goods sold (COGS) of designs.
• Defines and sets up product in electronic document control software.
• Performs other related duties and responsibilities as assigned.
  
  

Requirements

Qualifications

• Bachelor’s degree in mechanical engineering.
• Minimum 5 years of product development experience or 3 years of experience with a master’s degree in a related field.
• Knowledge of FDA, GMP, and ISO 13485; any experience with QSR implementation is desired, but not required.
• Proficient in designing products utilizing SolidWorks required.
• Proficient with Microsoft Office: Word, Excel, PowerPoint.
• Proven hands-on work experience and driven work ethic.
• Must be able to work independently with limited supervision.
• Demonstrated project management experience.
  
  

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
• Requires finger dexterity, repetitive motion, talking and hearing.
• 85% of time requires viewing and working at computer screen.
• Significant work pace & pressure due to deadlines.
• Travel 10%
  
  

The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.