Senior Product Engineer

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At Spectra, our goal is not to be good, it's to be extraordinary .

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Spectra Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

POSITION SUMMARY:

The desired candidate will have prior product development and engineering experience, preferably working in a medical device company. Specific experience and responsibilities will include, but are not limited to: leadership of design and development documentation under Design Control requirements for Spectra product lines and applicable customer products; define and execute all technical activities for assigned customer development projects; project management of customer projects; preparation of technical documentation for regulatory files (i.e. FDA 510k and CE mark technical files); support integration of materials, methods, and tools necessary to maintain current products and new product development; lead technical aspects of sourcing needs; update SOP and other R&D and engineering documentation.

ESSENTIAL FUNCTIONS / MAJOR RESPONSIBILITIES:

• Lead projects using project management techniques, for both customer and Spectra products, from conceptualization to design transfer.
• Lead new product development and design activities from concept through transfer to manufacturing, including preparation of design file documentation and project management for each design file / product line.
• Support maintenance of existing products including but not limited to design changes, process changes, supplier changes, remediation, recertification and brand extensions.
• Support engineering efforts for manufacturing equipment design and development.
• Remain current and proficient with US and International medical device regulations and standards.
• Working knowledge of common sterilization, biocompatibility, sterile packaging, shelf-life, and simulated distribution validation testing.
• Manage creation of engineering drawings for product, tooling, etc. in SolidWorks (3D) or CAD formats.
• Work with cross-functional partners to manage technical aspects of business including but not limited to CAPAs, regulatory filings, root cause identification, etc.
• Support customer projects with the sales department.
• Manage and facilitate customer interactions with clear communication as it relates to deliverables, technical solutions, and deadlines.
• Remain apprised of the progress of assigned projects, paying particular attention to any developing problems, and work with team members to resolve conflicts.
• Prepare applicable technical documentation for regulatory submission files (i.e. 510(k), CE technical file / design dossier, other regulatory bodies).
• Manage design control and engineering documentation for product/process changes requiring notification to regulatory bodies (design changes, process changes, supplier changes, remediation, recertification and brand extensions).
• Review and write standard operating procedures (SOPs).
• Collaborate with regulatory staff to evaluate product compliance to applicable regulations and project requirements.
• Turn concepts into reality by rapidly prototyping using a variety of fabrication techniques.
• Conduct feasibility testing, analyze, and report on test results providing conclusions and recommendations.
• Identify and implement opportunities for continuous improvement.
• Support sales and marketing at technical tradeshows, may include travel within the US.
• Travel as required to client sites, tradeshows, vendors and/or our manufacturing plant in Korea. Travel up to 25%.
• Perform other related duties and projects as business needs require at direction of management.

MINIMUM REQUIREMENTS:

• BS degree in Engineering.
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience.

PREFERRED SKILLSET:

• BS degree preferably in mechanical engineering, manufacturing engineering, or bio-medical engineering.
• 8+ years product design and development experience in a manufacturing or industrial environment, preferably in an FDA regulated environment.
• In-depth experience with ISO 13485, FDA QSR and EU MDR concepts and guidelines as well as other national and international regulations and standards.
• Excellent organizational, verbal, written communication and problem-solving skills.
• Possess above-average interpersonal skills demonstrating the ability to work with both internal and external stakeholders in a professional, positive and collaborative manner.
• Ability to work in a fast-paced environment, multi-task, and to meet tight deadlines.
• Reliability and attention to accuracy, detail, and timeliness.
• Willingness to learn, possess a positive attitude, and motivated to succeed and grow.
• Must be self-motivated and able to work with minimal supervision.
• Proficient in MS Office Suite, Visio, Project and Minitab, SolidWorks and other CAD software.
• Technical writing experience.
• Experience working in a start-up environment helpful.

PHYSICAL DEMANDS & ADA STATEMENT:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or HR to understand the Work Conditions and Physical requirements that may be specific to your role.

At-Will Employment: I acknowledge that my employment with the Company is on an at-will basis which means that either I or the Company can end the employment relationship at any time, for any reason, with or without prior notice.

An Equal Opportunity Employer: Spectra believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.