Sr. Product Engineer

Job Description

Tired of working at a "good" job? Aim higher!

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

Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.

Spectra Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, were 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.

As a Sr. Product Engineer with Spectra, you can experience extraordinary.

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 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 aspect 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 Solid Works (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 trade shows, may include travel within the US.
• Travel as required to client sites, trade shows, 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:

• Bachelors 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, preferred
• 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…