Senior Product Development Engineer II

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Spearhead strategic development initiatives for the design, creation, and launch of new products from initial concept to commercialization.

• Direct design efforts for new products, product modifications, and processes from ideation through feasibility to launch.

• Oversee intricate projects or platforms through prototyping, design and development, validation, and launch phases.

• Convert market and customer requirements into durable, manufacturable product designs.

• Manage and supervise prototyping, testing, validation, and compliance with regulatory standards.

• Create design plans, documentation, design reviews, DFMEA, PFMEA, hazard/risk mitigation strategies, and verification/validation tests.

• Develop specifications, bills of materials, technical packets, assembly instructions, and work instructions.

• Design, validate, and implement tooling and fixtures for manufacturing, assembly, and inspection processes.

• Review designs for manufacturability while verifying costs against project requirements.

• Assist in root cause investigations and corrective actions for design, performance, and quality concerns.

• Analyze existing products, identify enhancement opportunities, execute product improvement strategies, and update design and process validation documentation.

• Collaborate with manufacturing partners, contract manufacturers, designers, and product specialists to enhance designs, materials, and processes.

• Support stage-gate and design control processes until project completion.

• Engage with customers, marketing, sales, manufacturing, quality, and regulatory teams throughout the product lifecycle.

• Conduct feasibility studies and ROI analyses for capital improvement projects.

• Mentor and coach Level I/II engineers, review technical work, and provide direction.

• Advocate for continuous improvement in design standards, processes, and product performance.

• Validate and qualify new equipment and processes.

• Assist manufacturing teams with production challenges.

• Provide status updates to Engineering Management.

⛳️ Requirements

• Bachelor’s degree in an engineering, scientific, or technical field, or 10 years of relevant experience.

• Master’s degree or additional certifications (e.g., PMP, Six Sigma, PE license) preferred.

• At least 8 years of experience in product development, preferably related to single-use systems for biopharmaceutical markets, or in a regulated industry.

• Demonstrated success in managing complex design projects from concept to production.

• Strong understanding of 3D solid modeling, quality assurance standards, and interpretation of mechanical drawings.

• Proficient in tolerance analysis, GD&T, and design for manufacturability (DFM) principles.

• Experience in designing products within a manufacturing context with project leadership responsibilities.

• Analytical skills for assessing information and resolving complex challenges.

• Organizational skills for managing tasks, budgets, schedules, and leading project efforts.

• Experience working with cross-functional teams and taking on project leadership roles.

• Exceptional communication and interpersonal abilities.

• Familiarity with regulatory standards such as ISO, FDA, and IEC.

• Strong knowledge of manufacturing processes including injection molding, extrusion, machining, and 3D printing.

• Lean Six Sigma Green Belt or Lean Green Belt certification.

• Capability to communicate effectively, both written and verbally, with colleagues and supervisors.

• Ability to influence without formal authority and collaborate effectively across organizational boundaries.

• Strong problem-solving capabilities and a commitment to getting the job done.

• High attention to detail and dedication to product quality and performance.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and growth.

• Collaborative and innovative work environment.

• Flexible work arrangements.