Provide technical support based on project plans with both new development products and commercialized products.
All in compliance with design controls and processes in compliance with good manufacturing practices.
Complete relevant tasks to fulfill major milestones, identifying processing parameters, materials, equipment and requirements of products and process optimization.
Coordinate Design Change and Process Change activities.
Develop design inputs and design outputs for changes to existing products.
Provide R&D support for verification, qualification, and validation studies on existing products.
Support risk management activities and risk management reviews on existing products.
Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns.
Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation.
Support regulatory approvals and responses to regulatory questions for existing products.
Development of tests with human and animal tissue models.

Requirements

BS in Mechanical, Electrical or Biomedical Engineering, or equivalent
Minimum of 2 years related experience and/or training; or equivalent combination of education and experience
Strong understanding of engineering concepts and principles
Familiar with device assembly, tolerancing, and possess basic drafting skills
Able to develop test protocols and synthesize data to write test reports based on observed data, relevant test standards and general engineering knowledge
Familiarity with statistical analysis (e.g. two-sample t-test, tolerance limit calculation)
Familiarity with FDA, ISO and EN Standards as they apply to medical devices
Ability to travel up to 10%

Benefits

Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy.
Access to company sponsored wellness programs and mental health resources.
Paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
A competitive 401(k) plan with company match that vest immediately.
Financial planning services to help you secure your future.
Corporate discount programs for goods and services.
Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
A supportive work environment where everyone feels valued, and has a sense of belonging.
Participate in team-building activities, volunteer opportunities, and company-sponsored events.
Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

mechanical engineeringelectrical engineeringbiomedical engineeringdevice assemblytolerancingdrafting skillstest protocol developmentstatistical analysisdata synthesistest report writing

Soft skills

technical supportproject coordinationrisk managementproblem-solvingcommunication

Certifications

BS in Mechanical EngineeringBS in Electrical EngineeringBS in Biomedical Engineering