Mechanical Engineer

About the Organization
By joining the Instant Systems team, you will be at the forefront of innovation in med tech and biotechnology. You will work with innovative companies who are leading the way in creating lifesaving therapies for patients around the world. You will work side by side with your fellow team members to create future innovations for best patient outcomes. We are looking for strategic problem solvers who thrive in an autonomous environment of diverse and energized collaborators.

If you are motivated by new challenges and opportunities for skills growth, we welcome you to apply. Your energy and expertise is valuable, spend it making a difference on a worthy mission.

Description
The Mechanical Engineer is primarily responsible for leading new product development projects from concept to production readiness. The Mechanical Engineer drives innovation to fulfill client needs as well as the strategic direction of the company.

• Leading, participating, or supporting product development activities including concept, planning, design, and execution stages of new products or product enhancements
• Risk assessment
• Prototyping and testing concept designs and initial engineering builds
• Design reviews, verification testing, product validation, and usability testing
• Tech transfer to production
• Ensuring product launches occur on time every time
• Creating Design History Files
• Ensuring products are developed in compliance with applicable regulations, standards, and/or customer requirements
• Developing and project planning new products in line with customer design inputs and output needs
• Writing validation/qualification protocols and reports, and other required documents as per the Quality Management Systems at Instant Systems (e.g., SOPs, Work Instructions, Forms, etc.)
• Developing CAD designs and drawings required throughout the value stream of the company
• Drives continuous improvement through improvement and/or development in systems and processes
• Understanding and reporting on applicable product standards
• Maintaining delivery timelines on tasks and deliverables
• Evaluating proposed design modifications
• Setting accurate timelines for task completion
• Communicating deviations from original plans quickly to Client Services
• Providing accurate information for price quoting purposes
• Functioning as Subject Matter Expert (SME) to help resolve customer complaints, internal non-conformances, and/or Quality Improvement initiatives
• Consulting on quality tasks related to product development
• Reviewing final product documentation for accuracy
• Making recommendations to improve productivity, quality, and efficiency of operations

• A Bachelor’s degree in Engineering or relevant field.
• A minimum of 3 years of relevant work experience.
• Solid company-centric ideology.
• Creative problem‑solving skills.
• The ability to balance multiple priorities.
• Core values of honesty and respect.
• A thirst for learning.
• The desire to be challenged.

• Enjoy an autonomous work environment.
• Have a LEAN mindset.
• Are the first person to help.
• Seek out opportunities to bring added value.

• 401K
• Health Benefits:
  
  Medical, Dental, Vision
• Wellness Program
• Life Insurance
• Corporate Sponsored Events
• Skill growth opportunities
• Short Term Disability
• Ability to Advance
• Working with energetic & creative problem solvers
• A mission worthy of your energy and expertise

Applicants for this position must successfully pass a background and drug screening. It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company’s needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description.

The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

Instant Systems’ provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.