Job details
Job type full-time
Full job description
An opportunity exists for a senior test engineer to join the newest pure-play spine organization in the countrySurgalign is an emerging leader in the spine industry, tripling the size of our business over the past five yearsWe are a global medical technology company advancing the science of spine care, focused on delivering innovative solutions that drive superior clinical and economic outcomesSurgalign markets products throughout the united states and in more than 50 countries worldwideOur high-performing company and culture sets us apart from our peers and is what make us proud to work hereIf you want to be part of a team with a passion for winning, a focus on customer-centricity, a growth mindset, and a deep sense of accountability and teamwork, then this role is for youJoin us and be all in on spine.
Position summary:
Work closely with system engineering and development teams to define test methodologies for system and subsystem requirements.
Architect, execute and document formal verification and validation plansApply engineering expertise to develop test plans, coordinate testing across the organization, maintain traceability to requirements, and document results.
Create, validate, and maintain test tools and scripts to automate testing.
Maintain project plans and organized and efficient design control documentation.
Education/experience required and/or preferred:
A minimum of 3 years of related experience.
Preferred minimum of 3 years of experience in medical device development.
Preferred experience in one or more engineering fields.
Knowledge, skills, and abilities:
Demonstrated experience in fda requirements (21 cfr 820) and medical device development standards including iso 13485, iso 14971, iec 60601, iec 62366, and iec 62304.
Strong understanding and knowledge of testing methodologies of complex electromechanical systems with software applications.
Knowledgeable in developing test plans, protocols/test scripts, result reports.
Experience utilizing root cause analysis to identify any issues as they arise.
Preferred familiarity with requirements management and tracking tools such as jama and jira.
Preferred spine anatomy and procedures knowledge.
Excellent verbal and written communication skills.
Our values:
Be relentless, gritty & tenacious
Passion and perseverance over timeWe will not be knocked off course.
Act with speed
Making thoughtful decisions quicklyWe execute with intensity and operate with a send of urgency to best serve employees and customers.
Customer focused and patient minded
Putting the customer first at every level of the companyWe are fully committed to satisfying surgeons` needs to improve their patients’ lives.
Lead with integrity
Hold oneself to the highest ethical and quality standardsWe put honesty, transparency, and sound judgment above all else to deliver on our commitments.
Be bold & act courageously
Stand up for what is rightWe take risks, have difficult conversations, make bold decisions, and own the results.
Our mission:
We align with surgeons to improve patient lives by developing and delivering intelligent solutions for spine disordersWe do this through investment in exceptional talent
