Senior Mechanical Engineer - Consumables Design

We need to output HTML fragment with sections: About the role (maybe from Position Summary), Responsibilities, Requirements (Qualifications), Skills? The posting includes responsibilities, qualifications, preferred experience, etc. Also includes Salary range and location. According to rules: include a section only when posting has real, specific content. So we need sections: About the role (position summary), Responsibilities, Qualifications (maybe split into Required and Preferred?), Skills? The posting includes "Proficiency with GD&T, tolerance stack-up analysis, and CAD tools (e.g., SolidWorks)" etc. Could be part of Skills. But we can combine Qualifications and Skills into one section? The instruction: use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We need to decide which sections to include based on content. We have: - Position Summary: we can put under About the role. - Key Responsibilities: Responsibilities. - Technical Leadership & Client Interface, Cross-Functional Collaboration: these are part of responsibilities but could be subpoints; but we can keep under Responsibilities as list items. - Qualifications: Required and Preferred. We can have a Qualifications section with required and preferred as sublists? Or separate Required and Preferred? The instruction says use headings like Qualifications, Skills. We could have Qualifications (Required) and maybe Skills separate. But we have both required and preferred qualifications. Could combine into Qualifications section with two subheadings? But we cannot add extra headings not listed? The instruction says use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but suggests those as examples. Safer to stick to those headings. We could have Qualifications for required, and Skills for preferred? Or we could have Qualifications for required and preferred combined, and Skills for specific technical proficiencies (GD&T, CAD, etc). Let's parse: Qualifications Required list includes education, years experience, plastics design expertise, die cutting, coating, converting, plastics joining/welding, human factors, labeling/packaging, sterilization modalities, GD&T, CAD, leadership/communication. Preferred Experience includes fluid-path/wetted consumable design, ISO 10993, sterilization validation, home-use design, AI tools proficiency, patent experience. Thus we could have: - Qualifications (Required) as a list. - Skills (Preferred) as a list? But Skills heading could capture technical skills like GD&T, CAD, AI tools, etc. However the preferred includes many items that are also qualifications. Maybe better: Have Qualifications section for required, and Skills section for preferred (or both). But we need to avoid thin sections. Let's think: The posting has a lot of content; we can have: - About the role (position summary) - Responsibilities (key responsibilities + technical leadership & client interface + cross-functional collaboration) - Qualifications (required) - Skills (preferred + maybe some technical skills like GD&T, CAD, AI tools, patent experience) - Pay (salary range) - Benefits (mentions benefits, PTO, 401k with matching) - we have that. - Schedule? Not mentioned; we have onsite in San Diego (location). No schedule details. So we should not create Schedule section. - Benefits section: we have "benefits, PTO and 401k with matching". That's specific enough. Thus we will output:

About the role

...

Responsibilities

• ...
...

Qualifications

• ...
...

Skills

• ...
...

Pay

Salary range: $150,000-$185,000 plus benefits, PTO and 401k with matching

Benefits

Benefits, PTO and 401k with matching

but that duplicates Pay. Actually Pay section already includes benefits. We could combine Pay and Benefits into one Pay section that includes salary and benefits. But the instruction says create Pay/Schedule/Benefits sections only if posting actually states them. It states salary range and mentions benefits, PTO, 401k. So we could have Pay section with salary range and mention benefits. Benefits section could be redundant. Better to have Pay section include salary and benefits, and not create separate Benefits. But we have also mention of benefits separate? The sentence: "Salary range: $150,000-$185,000 plus benefits, PTO and 401k with matching". So we can put that in Pay section. No need separate Benefits. Thus sections: About the role, Responsibilities, Qualifications, Skills, Pay. Check if we need Requirements heading? Not needed if we have Qualifications. Now we need to preserve all substantive information, not invent or summarize away detail. Must not repeat job title as heading. Must not put Job ID etc. We need to extract all bullet points from responsibilities, qualifications, preferred experience. Let's list responsibilities from the text: Key Responsibilities: - Consumable & Plastics Design Lead mechanical design of consumable/disposable components (e.g., cartridges, cassettes, fluid-path sets, connectors, filters) for life-science instruments and medical devices. - Apply best-practice plastics design principles (wall thickness, draft angles, ribs/bosses, gate and parting-line placement) to ensure part manufacturability and performance. - Specify and validate plastics joining and welding methods (ultrasonic welding, heat staking, solvent bonding, laser welding) appropriate for fluid-path integrity and biocompatibility. - Evaluate materials for chemical compatibility and biocompatibility, partnering with Quality and Regulatory as needed. - Design sterile barrier packaging systems (e.g., pouches, trays, seals) suited to the target sterilization modality and shelf-life requirements. - Apply design-for-user-experience and human factors principles (IEC 62366) to consumable design, including error-proofing, tactile/visual feedback, and ease of loading for both clinical and home-use operators. - Design consumables for bioburden control and sterility assurance, including material selection and compatibility with sterilization modalities (EtO, gamma, e-beam). - Lead design-for-manufacture (DFM) and design-for-assembly (DFA) reviews with internal manufacturing/operations teams as well as external tooling vendors and contract manufacturing partners, including tolerance stack-up and GD&T analysis. - Lead verification testing of consumables (e.g., burst/leak testing, drop/shock, fatigue, shelf-life) to support design verification and validation. - Lead process validation efforts for consumables. - Support pilot builds and design-transfer activities, ensuring consumable designs are robust for high-volume manufacturing. Technical Leadership & Client Interface: - Serve as the technical authority on consumables design, manufacturability, and human factors across the program portfolio. - Present mechanical design status, risk assessments, and manufacturability trade-offs at design reviews and client meetings. - Mentor mechanical engineers on plastics design, DFM/DFA for both internal and external manufacturing, and sterility/bioburden best practices. - Represent the mechanical/consumables workstream credibly to clients, balancing innovation, manufacturability, and program constraints. Cross-Functional Collaboration: - Partner with process- and materials-focused engineering colleagues to ensure fluid-path materials and geometries meet chemical compatibility, biocompatibility, and performance requirements. - Partner with Systems Engineering to ensure consumable-level requirements are captured, traced, and verified within the system design-control framework. - Coordinate with Quality and Regulatory on biocompatibility (ISO 10993), sterilization validation, and design-history-file documentation. - Collaborate with Operations and Supply Chain on tooling strategy, supplier qualification, and scale-up planning. We can combine all these into a single Responsibilities list. Now Qualifications Required: - BS in Mechanical Engineering; MS preferred. - 7+ years of mechanical design experience, with significant focus on disposable/consumable components for IVD or human-use medical devices. - Deep, hands-on expertise in plastics design and injection molding, including resin selection, tooling considerations and DFM/DFA practices for both internal and external manufacturing. - Experience with die cutting, coating, converting and associated processes utilized in the production of high-volume consumables. - Direct experience specifying and validating plastics joining/welding methods (ultrasonic welding, heat staking, solvent bonding, or laser welding). - Demonstrated experience applying human factors and user-experience principles to consumable or disposable product design. - Working knowledge of labeling and primary and secondary packaging. - Working knowledge of sterilization modalities, bioburden control, and sterile packaging design for medical device consumables. - Proficiency with GD&T, tolerance stack-up analysis, and CAD tools (e.g., SolidWorks). - Strong leadership and written/verbal communication skills, with demonstrated ability to lead technically and interface credibly with clients. Preferred Experience (we can put under Skills): - Experience with fluid-path or wetted consumable design (e.g., cartridges, tubing sets, filters) in dialysis, infusion/IV therapy, diagnostics, or similar applications. - Familiarity with ISO 10993 biocompatibility testing and sterilization validation (ISO 11135, ISO 11137). - Experience designing consumables for home-use or lay-user environments. - Proficiency with AI tools. - Patent experience in consumable or disposable medical device design. Also location: "This role is onsite in San Diego." Could be included in About the role or a separate note. Since we don't have a Location heading, we can add a short paragraph in About the role or maybe a separate

after About the role. But we must not create extra headings unless needed. We can incorporate location into About the role paragraph. Now Pay: "Salary range: $150,000-$185,000 plus benefits, PTO and 401k with matching" Now we need to output HTML fragment only. Let's craft:

About the role

The Senior Mechanical Engineer leads mechanical design of disposable and consumable components for life-science instruments and medical devices. This role brings deep, hands-on expertise in plastics design, injection molding, and plastics joining/welding for IVD and human-use medical device consumables, along with a strong command of design for user experience, human factors, and bioburden/sterility control. The skill set is intended to support an ongoing portfolio of related development programs (for example, dialysis and other extracorporeal consumables, diagnostic cartridges or cassettes, drug-delivery consumables, and other single-use fluidic or reagent-handling components). The Senior Mechanical Engineer partners closely with chemical, systems, electrical, software, and human factors engineering to integrate fluidic, chemistry, controls, and usability requirements into manufacturable, reliable, and user-friendly consumable designs, while providing technical leadership and credible client interface throughout each program. This role is onsite in San Diego.

Responsibilities

• Lead mechanical design of consumable/disposable components (e.g., cartridges, cassettes, fluid-path sets, connectors, filters) for life-science instruments and medical devices.
• Apply best-practice plastics design principles (wall thickness, draft angles, ribs/bosses, gate and parting-line placement) to ensure part manufacturability and performance.
• Specify and validate plastics joining and welding methods (ultrasonic welding, heat staking, solvent bonding, laser welding) appropriate for fluid-path integrity and biocompatibility.
• Evaluate materials for chemical compatibility and biocompatibility, partnering with Quality and Regulatory as needed.
• Design sterile barrier packaging systems (e.g., pouches, trays, seals) suited to the target sterilization modality and shelf-life requirements