Sr Product Engineer

Tired of working at a good jobAim higher!

AtSpectra our goal is not to be good its to beextraordinary.

Extraordinaryperformance comes from extraordinary people. And the foundation forextraordinary people is extraordinary culture.

Our values describethe behaviors that define our unique culture. They are what set usapart and what makes us trusted leaders in our field.

Spectra Medical Devices is one of the worlds leadingmanufacturers of madetospec procedural needles. Beyond needles werealso a Contract Development and Manufacturing Organization (CDMO)to industryleading multinational healthcare companies globaloriginal equipment manufacturers (OEMs) and emerging technologycompanies.

We also distribute a wide range of complementarypharmaceutical products surgical instruments and medicalsupplies.

As a Sr. ProductEngineer with Spectra you can experience extraordinary.

POSITIONSUMMARY :

The desired candidatewill have prior product development and engineering experiencepreferably working in a medical device company.

• Specific experienceand responsibilities will include but not limited to : leadership ofdesign and development documentation under Design Controlrequirements for Spectra product lines and applicable customerproducts;
• define and execute all technical activities for assignedcustomer development projects; project management of customerprojects;
• preparation of technical documentation for regulatoryfiles (i.e. FDA 510k and CE mark technical files); supportintegration of materials methods and tools necessary to maintaincurrent products and new product development;

lead technical aspectof sourcing needs; update SOP and other R&D and engineeringdocumentation.

ESSENTIAL FUNCTIONS / MAJOR RESPONSIBILITIES :

• Lead projects using project management techniques forboth customer and Spectra products from conceptualization to designtransfer.
• Lead new product development anddesign activities from concept through transfer to manufacturingincluding preparation of design file documentation and projectmanagement for each design file / product line.
• Support maintenance of existing products including butnot limited to design changes process changes supplier changesremediation recertification and brand extensions.
• Support engineering efforts for manufacturing equipmentdesign and development.
• Remain current andproficient with US and International medical device regulations andstandards
• Working knowledge of commonsterilization biocompatibility sterile packaging shelflife andsimulated distribution validation testing.
• Manage creation of engineering drawings for producttooling etc. in SolidWorks (3D) or CAD formats.
• Work with crossfunctional partners to manage technicalaspects of business including but not limited to CAPAs regulatoryfilings root cause identification etc.
• Supportcustomer projects with the sales department.
• Manage and facilitate customer interactions with clearcommunication as it relates to deliverables technical solutions anddeadlines.
• Remainapprised of the progress of assigned projects paying particularattention to any developing problems and work with team members toresolve conflicts.
• Prepare applicable technicaldocumentation for regulatory submission files (i.e. 510(k) CEtechnical file / design dossier other regulatorybodies).
• Manage design control and engineeringdocumentation for product / process changes requiring notification toregulatory bodies (design changes process changes supplier changesremediation recertification and brandextensions)
• Review and write standard operatingprocedures (SOPs)
• Collaborate with regulatorystaff to evaluate product compliance to applicable regulations andproject requirements
• Turn concepts into realityby rapidly prototyping using a variety of fabricationtechniques.
• Conduct feasibility testing analyzeand report on test results providing conclusions andrecommendations.
• Identify and implementopportunities for continuous improvement
• Support sales and marketing at technicaltradeshows may include travel within theUS.
• Travel as required to client sitestradeshows vendors and / or our manufacturing plant in Korea. Travelup to 25%.
• Perform other related duties andprojects as business needs require at direction ofmanagement

MINIMUMREQUIREMENTS :

• Bachelors degree inEngineering
• Minimum of 5 years of relevant experience or advanced degree witha minimum of 4 years relevantexperience

PREFERREDSKILLSET :

• BS degreepreferably in mechanical engineering manufacturing engineering orbiomedical engineering.
• 8 years product designand development experience in a manufacturing or industrialenvironment preferably in an FDA regulated environmentpreferred
• In depth experience with ISO 13485FDA QSR and EU MDR concepts and guidelines as well as othernational and international regulations andstandards
• Excellent organizational verbalwritten communication and problemsolvingskills
• Possess aboveaverage interpersonalskills demonstrating the ability to work with both internal andexternal stakeholders in a professional positive and collaborativemanner
• Ability to work in a fastpacedenvironment multitask and to meet tightdeadlines
• Reliability and attention to accuracydetail and timeliness
• Willingness to learnpossess a positive attitude and motivated to succeed andgrow
• Must be selfmotivated and able to workwith minimal supervision
• Proficient in MSOffice Suite Visio Project and Minitab SolidWorks and other CADsoftware
• Technical writingexperience
• Experience working in a startupenvironment helpful

PHYSICAL DEMANDS & ADA STATEMENT :

The physical demands describedwithin the Responsibilities section of this job description arerepresentative of those that must be met by an employee tosuccessfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals withdisabilities to perform the essential functions. While performingthe duties of this job the employee is regularly required to beindependently mobile.

The employee is also required to interactwith a computer and communicate with peers and coworkers. Contactyour manager or HR to understand the Work Conditions and Physicalrequirements that may be specific to your role.

An Equal Opportunity Employer : Spectrabelieves that all persons are entitled to equal employmentopportunity. The Company will not discriminate or toleratediscrimination against any employee or applicant because of racecolor creed religion genetic information sex sexual orientationnational origin age status with regard to public assistance maritalor veteran status disability or any other characteristic protectedby local state or federal law.

Equal employment opportunity will beextended to all persons in all aspects of the employeremployeerelationship including recruitment hiring training promotiontransfer discipline layoff recall and termination.

Disabledapplicants may request any reasonable accommodation needed toenable them to complete the applicationprocess.

AnnualBonus Program

Excellent Health & WellnessPlans

401k With CompanyMatch

Remote Work :