Position Summary We are seeking a highly motivated Product Development & Sales Support Specialist to support the growth of our medical and surgical contract manufacturing business. This position will serve as a key link between customers, sales, engineering, quality, operations, and manufacturing throughout the product development and commercialization process. The ideal candidate will have a strong understanding of medical device manufacturing and be comfortable working with customers to understand product requirements, identify manufacturing solutions, develop preliminary concepts and cost estimates, and coordinate internal resources to move opportunities from initial inquiry through production. This is a hands-on, cross-functional position requiring a combination of technical understanding, project coordination, customer interaction, commercial awareness, and problem-solving skills . Key Responsibilities Product Development & Customer Support Work directly with customers to understand product requirements, specifications, performance expectations, and manufacturing challenges. Support development of new medical and surgical products from initial concept through prototype, validation, and production. Review customer drawings, specifications, samples, bills of materials, and other technical documentation. Identify potential manufacturing methods, materials, tooling requirements, assembly processes, and production considerations. Coordinate with engineering and manufacturing teams to evaluate product manufacturability and recommend design-for-manufacturing improvements. Participate in design reviews and customer technical meetings. Help identify opportunities to reduce cost, improve quality, simplify assembly, and improve manufacturability. Support prototype and first-article builds and coordinate customer feedback and revisions. Maintain clear documentation of product requirements, development activities, open issues, and customer decisions. Sales Support & Business Development Support the sales team in evaluating new customer opportunities and determining technical and commercial feasibility. Respond to customer RFQs and product inquiries by coordinating technical reviews, costing, tooling requirements, lead times, and manufacturing assumptions. Research preliminary cost estimates and quotations in coordination with sales, engineering, operations, and finance. Develop a strong understanding of customer products, markets, competitors, and future development needs. Help transition new business opportunities from sales into formal product development and manufacturing programs. Cross-Functional Project Coordination Act as a central point of communication between customers and internal technical and operational teams. Coordinate activities across engineering, quality, tooling, purchasing, production, and sales. Track development milestones, deliverables, customer approvals, and open issues. Help ensure customer expectations regarding cost, quality, timing, and technical requirements are clearly communicated internally. Support new product introduction (NPI) activities and commercialization. Assist with resolving technical or manufacturing issues that arise during development and early production. Medical Device / Quality Responsibilities Work within the company's quality management system and applicable medical device requirements. Support compliance with applicable

FDA, ISO

13485, and customer-specific requirements. Assist with development and review of product specifications, manufacturing documentation, and other quality-related documentation. Support customer audits, technical questionnaires, and supplier qualification activities as needed. Understand the importance of traceability, documentation, process validation, change control, and risk management in medical device manufacturing. Qualifications Required Bachelor's degree in engineering, manufacturing, business, or a related technical field; equivalent industry experience may be considered. 1+ years of experience in medical device, medical/surgical, plastics, contract manufacturing, or a related manufacturing environment. Ability to understand engineering drawings, specifications, BOMs, and manufacturing processes. Strong written and verbal communication skills. Ability to work effectively with customers as well as internal engineering and manufacturing teams. Strong organizational and project coordination skills. Ability to understand technical information and translate it into practical manufacturing and commercial considerations. Proficiency with Microsoft Office Preferred Experience with injection molding, extrusion, thermoforming, assembly, machining, or other medical device manufacturing processes. Experience supporting RFQs, quotations, costing, or new business development. Experience with medical or surgical products. Familiarity with ISO 13485 and FDA medical device requirements. Experience with design-for-manufacturing (DFM). Experience working with engineering drawings and CAD documentation. Experience with ERP, CRM, or product lifecycle management systems. Previous customer-facing technical or applications engineering experience.

Key Competencies Customer Focus:

Builds strong customer relationships and understands the customer's technical and commercial objectives.

Technical Understanding:

Quickly understands products, materials, processes, and manufacturing requirements.

Commercial Mindset:

Recognizes opportunities, understands cost drivers, and supports profitable business growth.

Problem Solving:

Identifies practical solutions to technical and manufacturing challenges.

Communication:

Clearly communicates complex technical information to both technical and non-technical audiences.

Project Management:

Effectively coordinates multiple projects, priorities, and deadlines.

Collaboration:

Works effectively across sales, engineering, quality, operations, and manufacturing. Attention to

Detail:

Maintains accuracy in specifications, quotations, documentation, and customer requirements.

Initiative:

Proactively identifies opportunities to improve products, processes, customer relationships, and business opportunities. Performance Measures Success in this position will be measured by: Growth in qualified new business opportunities. Successful conversion of RFQs into new programs. Accuracy and responsiveness of customer quotations and technical responses. Successful transition of new products from development into production. Customer satisfaction and responsiveness. Development project timing and execution. Identification of cost-reduction and manufacturing-improvement opportunities.

Position Characteristics Department:

Product Development Reports To:

V.

P & General Manager Position Type:

Full-Time Pay:

$60,000.00 - $76,000.00 per year

Benefits:

Health insurance Paid time off

Work Location:

In person