Are you driven to optimize manufacturing processes and continuously striving to produce product of ever greater safety, quality and output? Are you highly motivated to deliver the best value for our customers through creative solutions?
If your answer is yes, then we may be looking for you!
Spectranetics, recently named one of the “Most Trusted Companies”, has an opening for a Temporary Manufacturing Engineer.
What You Will Do: You will be responsible developing CAD drawings/models of production fixtures that will include all material specifications, critical and noncritical dimensions and parts lists as required by the QSR and ISO guidelines. You will evaluate manufacturing operations' SOPs and risk assessment documents to create receiving inspection plans to specify inspection parameters, sampling plan and methodology, while also validating our existing calibration and preventive maintenance documents to ensure they are adequate and up to date as necessary. You will also execute a receiving inspection plan or installation qualification for all existingixtures.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from your fellow Engineers, Clinicians, Sales Leaders, and other industry professionals about our state of the art products.
What You Will Become: A highly influential driver who will be key in helping achieve our mission of delivering consistent high quality, safe and effective, regulatory compliant products and services.
What Success Looks Like:
Create CAD models for manufacturing fixtures that specify all dimensions, materials, and parts required to meet the function of the tool. The drawings should provide adequate detail to ensure a machine shop could fabricate the customized fixture.
Develop a functional understand of all manufacturing fixtures through direct observation or evaluation of operation SOP's to determine critical fixture properties.
Create technical documents and utilize the Agile change management system to gain customer approval of proposed changes to existing or new documents.
Act as subject matter expert (SME) regarding equipment preventive maintenance and calibration requirements.
Partner with the calibration technician to validate existing procedures are adequate or update procedures as needed.
Partner with maintenance technicians to properly document all requirements of the preventive maintenance SOP template.
Develop an understanding of the corrective maintenance history for each fixture to develop effective preventive maintenance standards and spare parts lists.
Research suppliers for spare parts and document the required purchasing information.
Develop an understanding of each fixture's function and its impact on the product and ultimately the patient to develop a risk profile for each fixture.
Determine fixture part dimensional tolerances based on its function and risk profile.
Execute the receiving inspection or installation qualification for all existing fixtures. Document each inspection or qualification on the appropriate report and submit report in Agile for approval.
BS Degree or equivalent work experience
5-10 years' experience working within engineering or technical project team environments.
10+ years working within technology fields involving electro-mechanical equipment, automation, and lean production processes.
Excellent electrical and mechanical troubleshooting skill sets including conceptual design awareness and hands-on practical knowledge.
Ability to work independently, with a proactive sense of urgency.
Direct experience working within FDA CFR 21 820 controlled environments.
Material and Equipment Directly Used:
General measuring equipment such as calipers, micrometers, and tensile test equipment
Computers and applicable software packages – SolidWorks & Agile document control experience preferred.
Applicable production fixtures, appropriate tools, as necessary
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
All applicants must pass a pre-employment drug screen to be hired. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability.